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Life Science Webinars

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Upcoming Webinars

Welcome to the life science webinar program. Our subject matter experts cover many subjects, ranging from biopharmaceutical manufacturing to biology, chemistry, and water purification. From regulation, cell culture, and emerging technologies to laboratory trends & tips, our team of leading scientists is here to help. Join us for live conversations, panel discussions, and Q&A sessions, or listen to our on-demand webinars at your convenience.


Intensified and Faster Processing of Chromatography Unit Operation by Membrane Chromatography

Subcategory: Downstream
Duration: 1 hour
Date: 8 October, 2024

Time: 2:00 pm SGT 3:00 pm KST 11:00 am IST

In this webinar, you will learn:
  • What is membrane chromatography
  • Features and operational flexibility of membrane chromatography
  • Impact on process economics
Detailed description:
Membrane chromatography is a technique which can be utilized for initial capture steps all the way through polishing. Join us for a webinar exploring the latest developments in chromatography and applications of membrane chromatography in Bioprocessing. This technology has emerged as a powerful tool for improving efficiency and productivity in protein purification for biopharmaceutical manufacturing.

Speakers:
Speaker
Nirlon Patel
Merck
Technical Application Expert, Downstream
Speaker
Nitish Kumar
Merck
Head of Downstream, India

Ahead of the Curve: Applying Cutting-edge NGS Technology within Biologics Manufacturing

Subcategory: Regulatory
Duration: 1 hour
Date: 17 October, 2024

Time: 7:00 am PDT 10:00 am EDT 4:00 pm CEST

In this webinar, you will learn:
  • How cutting-edge NGS technology can be applied to biosafety and characterization testing to fulfil regulatory requirements
  • Where NGS fits into your process and how to leverage an expert testing partner
  • How including NGS in your testing portfolio can support corporate 3R sustainability goals for transitioning from in vivo testing
Detailed description:
Next Generation Sequencing (NGS) is not a new technology, however its application in biosafety testing and characterization is more recent. With NGS gaining regulatory acceptance for various testing applications within the biologics space, now is the perfect time to incorporate NGS into your testing programs. This webinar explores how NGS is being used in a cross-functional manner for required regulatory testing and will focus on applications such as: Identity with variant detection, adventitious virus detection, on/off target analysis for gene editors, genetic stability, and AAV characterization. Join us to learn more about this technology and its applications from leaders in the field.

Speakers:
Speaker
Bradley Hasson
Merck
Director of Lab Operations for Next Generation Sequencing Services
 
 
 
 

Nitrosamines Risk Assessment: Role of Excipients

Subcategory: Regulatory
Duration: 1 hour
Date: 19 November, 2024

Time: 2:00 pm SGT 3:00 pm JST 11:30 am IST

In this webinar, you will learn:
  • Nitrosamine impurities
  • Updates on regulatory expectations
  • Role of excipients in risk assessment
Detailed description:
N-nitrosamines are classified as probable human carcinogens, necessitating that drug substance and drug product manufacturers implement measures to reduce or prevent nitrosamine impurities in APIs and drug products. This requires comprehensive risk assessments to evaluate nitrosamine levels and implement effective mitigation strategies.

Several factors contribute to nitrosamine formation or contamination, including the presence of nitrites in excipients, which pose risks when combined with vulnerable amines during manufacturing and storage. This presentation will offer insights into nitrosamine impurities, updates on regulatory expectations, and the critical role of excipients in assessing nitrosamine risks in pharmaceutical products.

Speaker:
Speaker
Saroj Varavadekar
Merck
Head of Regulatory Management, India, Life Science
 
 
 
 

Webinars: On Demand


To begin, please select a category:

Analytics & Sample Preparation

Browse subcategory:

Subcategory: Chromatography

New Column Modalities for Improved Biomolecule Separations

Subcategory: Chromatography

The purpose of this webinar is to discuss two column modalities that have now expanded their utility into the large molecule separations arena: monolithic silica columns and superficially porous particle (SPP) packed columns.

Abstract:
Selected aspects of the physical parameters of the stationary phase will be discussed in relation to improved efficiencies and throughput over traditional fully porous particle (FPP) packed columns. In addition, applications illustrating the relevance of these column modalities in regard to characterizing biomacromolecules and advantages of these column modalities over FPP packed columns will be presented and discussed.

By attending this webinar you will learn:
  • the advantages of using these two column modalities over traditional fully porous particle packed columns
  • techniques in separating biomacromolecules (top-down, bottom-up, middle-up/down analyses) by reversed-phase chromatography
  • aspects of method development in reversed-phase chromatography of biomacromolecules
Speaker:
Dr. Egidijus <strong>Machtejevas</strong>
Dr. Egidijus Machtejevas
Merck
Senior Product Manager Instrument Analytics, Advanced Analytics

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Solutions for Mass Spectrometry: Tips, Tricks and Applications

Subcategory: Chromatography

The webinar covers tips and tricks for optimizing your coupling liquid chromatography with Mass Spectrometry including: General considerations, mobile phase quality and contamination, solvent storage, equipment cleaning, buffers, Column bleeding and washing. Sensitivity, column robustness and lifetime are discussed, using application examples in LC-MS. Additionally, how to correctly analyze dirty samples with LC-MS is explored.

Speaker:
Dr. Stephan Altmaier
Dr. Stephan Altmaier
Merck
Head of Application Laboratory HPLC-MS, Advanced Analytics

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Chromatographic Solutions to Improve Food Safety

Subcategory: Chromatography

The presentation will introduce strategies/solutions to improve food safety using different chromatographic techniques (sample preparation, HPLC/UHPLC, TLC/HPTLC). Scandals in recent years have clearly proven that better testing is required. Techniques have to be more selective, quicker and with higher sensitivity. The talk will discuss the analytical possibilities from a molecular perspective, thus how it is possible to develop a suitable method using the most appropriate analytical technique. The aim with the presentation is that the attendees afterwards will consider the molecule(s) first and choose the most suitable technique from that perspective.

Speaker:
Dr. Patrik Appelblad
Dr. Patrik Appelblad
Merck
Technical Marketing Manager, Applications, Advanced Analytical

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Trouble-Free HPLC Analysis of Creams and Lotions: Beautiful Separations of Beauty Products

Subcategory: Chromatography

In this web seminar, we will demonstrate the benefits of using monolithic silica columns, illustrating those benefits with the numerous experimental data and detailed application examples on a variety of "creamy" sample types.

Matrix rich samples such as creams, lotions and lipsticks present analytical challenges. Monolithic silica columns can be of great benefit when dealing with samples like these. In contrast to conventional particle-packed columns, monolithic silica columns are made of a continuous piece of high purity porous silica. High permeability and porosity of the silica skeleton and the resulting low backpressure allow for more flexible flow rates compared to particulate columns. This enables high throughput and robust analysis without loss of separation efficiency or peak capacity — even for relatively "dirty" samples.

Speaker:
Dr. Egidijus Machtejevas
Dr. Egidijus Machtejevas
Merck
Senior Product Manager Instrument Analytics, Advanced Analytics

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Complete Solutions Regulated Pharmaceutical Instrumental Analysis

Subcategory: Chromatography

This webinar is for anybody who is analysing pharma compounds and is interested in up-to-date information about the United States Pharmacopeia (USP) and National Formula (NF) including upcoming changes.

Abstract:
There are a number of important questions that must be considered when analyzing pharma compounds:
  • How do I comply with the requirements in a monograph?
  • Can the method be optimized or changed? Is there a faster technique?
  • Is this the right grade of chemical for the analysis?
Using examples from four selected blockbuster molecules that have recently come off patent, or will do so by 2016, this webinar presents details of updated monograph methods describing HPLC, FTIR, Karl Fischer Titration, AAS and ICP methods and we demonstrate how state-of-the-art products simplify analysis of different types of drugs. You will also receive up-to-date information about the United States Pharmacopeia (USP) and National Formulary (NF), including upcoming changes.

Speaker:
Dr. Patrik Appelblad
Dr. Patrik Appelblad
Merck
Technical Marketing Manager, Applications, Advanced Analytical

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Complete Solutions for Dissolution Testing - Monograph Methods for Tablets and Capsules

Subcategory: Chromatography

In this webinar you will learn about dissolution testing using a few selected formulated small molecule drugs as examples. The application examples follow the current USP 37 - NF32 monographs and are all compliant with USP 38 - NF33 and the given suitability requirements. In addition to the application examples, the important role of filtration will be discussed in relation to dissolution testing, along with an examination of what changes are possible to the monograph methods.

Dissolution testing is an integral part of the drug development lifecycle. The goals of dissolution testing change as the drug moves through the different stages of development. The effectiveness of different drug dosage forms relies on the drug dissolving in a predictable manner prior to absorption into the body. It is also important to optimize the drug's bioavailability over time and deviations from expected dissolution profiles mean that treatment could be either ineffective or dangerous to the patient.

In this webinar you will learn:
  • Basics of dissolution testing using small molecule drugs as examples
  • The role of filtration in dissolution testing
  • What changes are possible to the monograph methods on dissolution testing
Speaker:
Dr. Patrik Appelblad
Dr. Patrik Appelblad
Merck
Technical Marketing Manager, Applications, Advanced Analytical

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Coupling Thin Layer Chromatography to Mass Spectrometry: A combination of two powerful analytical methods

Subcategory: Chromatography

Attendees of the webinar will learn which instruments are available, how to ensure reliable results with the technique, and through the presentation of application examples, what additional value the technique can provide.

The surge in interest of coupling thin layer chromatography (TLC) with mass spectrometry (MS) is due to the availability of commercial instruments that make the routine use of this technique possible. By coupling the advantages of TLC, such as the ability to separate many samples in parallel and the high matrix tolerance of this technique with MS, the TLC-MS becomes a powerful tool in the modern analytical environment.

Speaker:
Dr. Patrik Appelblad
Michael Schultz
Merck
Head of Instrumental Analyics R&D

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Transfer of USP Methods from Particulate to Monolithic Columns

Subcategory: Chromatography

This webinar will focus on regulated chromatographic analysis and how methods can be transferred from one type of column to another with the same chemistry but with different backbones and physical properties. USP monograph methods, originally developed and validated for use with large particle HPLC columns, have been transferred and partially revalidated for use with monolithic columns. The examples in this webinar will be used to emphasis the new possibilities in changing HPLC methods per chapter 621 in United States Pharmacopeia.

Speaker:
Dr. Patrik Appelblad
Dr. Patrik Appelblad
Merck
Technical Marketing Manager, Applications, Advanced Analytical

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SPME Method Development for Food Analysis

Subcategory: Chromatography

Given that SPME is an environmentally friendly sample preparation technique, the interest towards its implementation to a variety of applications continues to increase. However, quite often SPME is not utilized to its full potential due to the lack of proper training. In this webinar, we will be focusing on the implementation of SPME methods for food analysis, including optimization of the factors affecting SPME efficiency; special considerations for targeted and non-targeted applications; quantitation in SPME; and novel SPME devices and future directions.

What will you learn?
  • Introduction to SPME fundamentals
  • How to develop a SPME method for food and beverage analysis: special attention to complex matrices
  • How to perform quantitative SPME (calibration methods and choice of internal standard in SPME)
  • Future directions and development of new SPME devices
Why should you attend?
We will be providing the necessary tools for potential and current SPME users wishing to gain a deeper understanding into the SPME method and thus increasing their productivity.

Who should attend?
  • Chemists responsible for method development, analytical chemists, laboratory supervisors, scientists and industry regulators who are challenged by complex matrices and laborious sample preparation methods
  • Scientists wishing to implement SPME as a quantitative method
  • Professionals in academia and industry working in the areas of food and beverage interested in implementing SPME as a high throughput method to analyse trace-levels of pesticides.
Speaker:
Erica A. Souza-Silva
Erica A. Souza-Silva
Federal University of Rio Grande do Sul, Brazil
Postdoctoral Research Fellow

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Subcategory: Classical Analysis

Cleaner: How to Ensure Effective, Reliable and Safe Cleaning Procedures in Your Laboratory

Subcategory: Classical Analysis

This seminar illustrates characteristics of lab cleaning processes affected by regulations, standards and individual environments and requirements. It also covers essential application topics (e.g. validation procedures) and provides guidelines on how to carry out daily cleaning effectively, safely and with a focus on environmental protection.

Abstract:
Thorough, residue-free cleaning is essential for reliable processes. This applies to both laboratories and production facilities. Everything that comes into contact with chemicals or biological substances must be free of impurities, both before and after use.

By attending this webinar you will learn:
Participants will learn about specifics of applicable cleaning standards. Furthermore, ways to improve cleaning process effectiveness will be explored, with a view to helping you achieve reliable analytical results. In this seminar, detergent characteristics and practical guidelines (e.g. validation methods) will also be covered, as well as application examples for individual cleaning processes.

Who Should Attend:
Staff and managers of chemical labs (e.g. quality control, research).

Speaker:
Annett Schneider
Annett Schneider
Merck
Global Product Manager Safety & Essential Applications

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Subcategory: Test Kits and Photometric Methods

Beer analysis without the headache: Chemical and Microbiological Monitoring for Breweries

Subcategory: Chromatography

Monitoring a range of parameters such as bitterness, sulfite content, and spoilage contaminants throughout the beer making process ensures that you can produce safe, delicious, and high-quality beer. Sign up for our webinar where we will cover how to streamline both your chemical and microbiological analysis workflows.

Chemical and microbiological monitoring for breweries:
  • Light but full-bodied beer analysis: Sulfur dioxide analysis in beer made easy using spectroscopy
    Fabian Zieschang
  • Microbial spoilage detection in beer: workflow optimization for beer membrane filtration
    Samuel Santiago
Learning objectives:
  • Learn how to monitor sulfur dioxide in beer
  • Compare photometric analysis, using test kits, with common methods
  • Learn how to easily use analytical test kits & photometers
  • Perform membrane filtration in microbial analysis and use more viable options
  • Streamline your workflow
  • Gain knowledge on how to reduce false negative/positive results
Speakers:
Dr. Fabian Zieschang
Dr. Fabian Zieschang
Merck
Global Product Manager, Photometers and Analytical Test Kits
Samuel Soriano Santiago
Samuel Soriano Santiago
Merck
Global Product Manager

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Drinking Water Monitoring and Ultra-sensitive Measurement of Iron in Water

Subcategory: Test Kits and Photometric Methods

Water and especially drinking or bottled water monitoring is of great importance: Besides health-hazard aspects for humans (for instance nitrate in drinking water) — it also includes sensory and technical reasons. The presentation focuses on the ultra-sensitive measurement of iron by an photometric method compared to ICP-MS analysis. You will learn more about monitoring of chemical parameters in drinking water with focus on an ultrasensitive photometric analysis for measuring iron in water.

Speakers:
Dr. Fabian Zieschang
Dr. Fabian Zieschang
Merck
Global Product Manager, Photometers and Analytical Test Kits
Carolin Klein
Carolin Klein
Merck
Global Product Manager, Photometry

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Measuring Phosphate in Ground and Surface Water

Subcategory: Test Kits and Photometric Methods

This event will provide scientists with updates on the latest issues faced by individuals working in these challenging analytical fields.

Separation Science, in collaboration with MilliporeSigma has developed an online eSeminar focusing on the use and application of UV-vis spectrophotometry for the analysis of water. Taking place in a 1-hr session, this unique event will feaure technology experts and provide an interactive learning environment and online resource.

Featured Speakers and Presentations:

Sensitive and Reliable Measurement of ortho-Phosphate in Ground and Surface Water by Carolin Klein
This presentation concentrates on a photometric method that can be used to detect ortho-phosphate levels as low as 2.5 µg/L. Examples demonstrated are surface water samples from lakes in Germany with their phosphate levels measured using photometry. This is an important application, because too high levels of phosphate may pose a risk to both human health and the environment.

Analysing Phosphonates in Cooling and Boiler Water by Onur Akbulut
Organic phosphonate salts are mainly used in industrial cooling and boiler water applications. As antiscalants and corrosion inhibitors, the main purpose of phosphonates (organic phosphorus) is to reduce scale and remove rust, and thus lower maintenance costs. For an efficient and smooth-running system, both dosing and monitoring the concentration of phosphonates(in circulation in the system), are crucial for boiler water. Therefore, accurate and sensitive determination of phosphonates is necessarily the cornerstone of laboratory analysis.

Speakers:
Onur Akbulut
Onur Akbulut
Merck
Regional Field Marketing Manager, Advanced Analytics
Carolin Klein
Carolin Klein
Merck
Global Product Manager, Photometry

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UV-vis Spectrophotometric Analysis of Water, Food, and Beverages

Subcategory: Test Kits and Photometric Methods

This eSeminar focuses on the use and application of UV-vis spectrophotometry for the analysis of water, food, and beverages.

Abstract:
This one-day event will provide scientists with updates on the latest issues faced by individuals working in these challenging analytical fields. Taking place in one 2-hr session, this unique event will bring together a selection of technology experts and provide an interactive learning environment and online resource.

Featured Presentations:
  • Economic and Hassle-free Bromate Analysis in Drinking Water - Carolin Klein
  • An Overview of UV-vis Spectrophotometry Applications in the Craft Brewing Industry - Rick Blankemeier
  • Measurement of Caffeine in Coffee Beans by UV-vis Spectrophotometry - Abebe Belay Gemta
Two Speakers:
Carolin Klein
Carolin Klein
Merck
Global Product Manager, Photometry
Rick Blankemeier
Rick Blankemeier
Stone Brewing Co., USA
Quality Assurance Manager
Abebe Belay Gemta
Abebe Belay Gemta
Adama Science and Technology University, Ethiopia

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Ultra-Sensitive Silicate Analysis in Process and Boiler Water

Subcategory: Test Kits and Photometric Methods

The webinar will discuss photometric methods for analysis of silicate in boiler and process water using an ultrasensitive photometric technique. This technique is presented as an alternative to the graphite furnace atomic absorption technique. The webinar is aimed at anyone performing water analysis on boiler and cooling water, and/or anyone interested in silicate analyses.

By attending this webinar you will learn:
  • About ultrasensitive photometric methods for measuring silicates in boiler and process water
  • Instruments and test kits from MilliporeSigma for the application of this technique
  • Comparison data to GFAAS methods
Speaker:
Bruce Herzig
Bruce Herzig
Merck
Application Scientist

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Subcategory: Titration

Best Practices in Karl Fischer Titration


Precise and accurate results of the determination of water contents are important for the quality of raw materials used in production processes and also for the finished products. The main challenge is how to produce reliable and comparable results by choosing the right application method, instrument and reagents for your Karl Fischer Titration.

What Does it Cover?
Precise and accurate results of the determination of water contents are important for the quality of raw materials used in production processes and also for the finished products. The main challenge is how to produce reliable and comparable results by choosing the right application method, instrument and reagents for your Karl Fischer Titration.

What Will You Learn?
  • How to do a precise titer determination and instrument check and how you can detect and avoid influences on your titration results.
  • What needs to be considered when testing samples (e.g., influence of side reaction or insoluble substances.)
  • Many practical hints for the daily water determination.
Speakers:
Bettina Straub-Jubb
Bettina Straub-Jubb
Merck
Global Product Manager
Valeria Gärtner
Valeria Gärtner
Mettler Toledo GmbH, Schwerzenbach, Switzerland
Global Product Manager

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Industrial Microbiology

Browse subcategory:

Subcategory: Sterile Membrane Filtration

6 Impacts of Your Membrane Filtration Funnel Choice on Your Workflow

Subcategory: Sterile Membrane Filtration
Duration: 1 hour
Date: 7 June, 2018

Sterile membrane filtration is the preferred microbiological method in most industries for filterable samples. Should you use reusable or single-used funnels? We will discuss the various factors that need to be considered when determining the type of funnel for your purposes.

Speakers:
Speaker
Adrien Venchiarutti
Merck
Technical Marketing Manager
Speaker
Samuel Soriano Santiago
Merck
Global Product Manager

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Subcategory: Industrial Microbiology Misc.

What you need to know about the new ISO 16140-3 on microbiological method verification

Subcategory: Industrial Microbiology Misc.
Duration: 1 hour
Date: 18 February, 2021

The webinar introduces the new EN ISO 16140-3 on the verification of methods in food microbiology. This standard provides the protocols and criteria to demonstrate that a user laboratory can satisfactorily perform a validated method and that this method is fit for its intended purpose.

This webinar is intended for microbiological laboratory managers, technicians, and quality assurance teams.

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ISO 11133 Culture Media Quality Assurance: Latest Updates and Practical Lab Tips

Subcategory: Industrial Microbiology Misc.
Duration: 1 hour

This webinar will give practical tips for daily handling of culture media including preparation, shelf-life testing, microbiological and physical performance testing amongst other topics.

Abstract:
ISO 11133:2014 is a mandatory standard for all ISO 17025-accredited labs for microbiological analysis of food, feed and water. It is also widely used by non-accredited labs. ISO 11133 and its latest amendments describes the preparation, production and performance testing of culture media from this whole area. Since its publication as a full ISO standard for food and water microbiology, it has been implemented in many labs, but still there are many open questions for the daily lab work.

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Short Talk: Compliant Detection and Enumeration of Campylobacter spp. in Food & Environmental Samples

Subcategory: Industrial Microbiology Misc.
Duration: 20 minutes

We will guide you through the testing workflow according to ISO 10272, FDA-BAM and USDA-FSIS, and show you how we make the regulatory compliance of our testing solutions transparent.

Abstract:
Campylobacter spp. is a leading human pathogen worldwide that causes the foodborne illness Campylobacteriosis. The testing workflow is regulated by international organizations to ensure consumer safety. But how can you stay compliant with these regulatory standards and ensure the most accurate results? Watch our 20-minute talk to learn about the foods and conditions that can cause Campylobacteriosis and the international standards that regulate the detection and enumeration of Campylobacter.

Speaker:
Speaker
Dr. Andreas Bubert
Merck
Senior Product Manager
 
 
 
 

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Short Talk: Detection of Listeria monocytogenes in Food and Environmental Samples

Subcategory: Industrial Microbiology Misc.
Duration: 20 minutes

20-minute talk: detection of Listeria monocytogenes according to international standards

Abstract:
Listeria is a widespread microorganism in nature and Listeria monocytogenes is one of the most harmful pathogens which can cause serious foodborne illnesses and infections. It is therefore crucial to test food products and lab environments for Listeria monocytogenes. The testing workflow is regulated by international organizations to ensure consumer safety. But how can you stay compliant with these regulatory standards and ensure the most accurate results? We will walk you through the Listeria monocytogenes testing workflow according to ISO 11290, FDA-BAM and USDA-FSIS, and show you our solutions which will help you to stay compliant.

Speaker:
Speaker
Dr. Andreas Bubert
Merck
Senior Product Manager
 
 
 
 

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Monocyte Activation Test: A Powerful Tool to Assess Pyrogenic Risk in the Pharmaceutical Process

Subcategory: Industrial Microbiology Misc.
Duration: 24 minutes
Presented: 9 April, 2019

The monocyte activation test performed with the PyroMAT™ System detects endotoxin and non-endotoxin pyrogens.

Abstract:
Microbial risk in pharmaceutical process is not limited to living microorganisms and intact microbial cells. Subcellular components from microorganisms remaining from the production process can be source of pyrogens, compromising product quality and patient safety as these substances are not eliminated by classical filtration or sterilization steps.

Key topics include:
  • The microbial risk in pharmaceutical process cannot be limited to viable microorganisms
  • Performing an endotoxin test for product release may not be enough to ensure patient safety
  • MAT can help you to assess the pyrogenic risk resulting from your production process
  • The PyroMAT™ System has shown its ability to detect a panel of non-endotoxin pyrogen contaminants

Speaker:
Mathilde Arnault
Merck
Research Scientist
 
 
 
 

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Food Microbiology Regulatory Update: New & Revised ISO 11133 and ISO 17410 Standards

Subcategory: Industrial Microbiology Misc.
Duration: 60 minutes
Presented: 27 June, 2019

This webinar covers the latest news on ISO standards for culture media testing (ISO 11133), the enumeration of psychrotrophic microorganisms (ISO 17410) and an outlook for future new and revised ISO standards.

Abstract:
ISO 11133:2014+Amd1:2018 is a mandatory standard for all ISO 17025-accredited labs for microbiological analysis of food, feed and water. It describes the preparation, production and performance testing of culture media from this whole area. Planned publication of amendment 2:2019 contains the control strains for the performance testing of confirmation and characterization media, reagents, dyes, stains and materials described in standards for the microbiological examination of samples from the food chain and water.

The technically revised edition of ISO 17410 specifies a horizontal method for the enumeration of psychrotrophic microorganisms that are able to grow at 6.5°C. It replaces ISO 6730:2005 (IDF 101:2005), "Milk — Enumeration of colony forming units of psychrotrophic microorganisms — Colony-count technique at 6.5°C" and ISO 8552:2004 (IDF 132:2004) "Milk — Estimation of psychrotrophic microorganisms — Colony count technique at 21°C (Rapid method)".

This webinar explains the latest changes in ISO 11133 including its amendments and in ISO 17410 and will give an outlook on the future of these both standards and other ISO standards.

Speakers:
Speaker
Barbara Gerten
Merck
Application Training Scientist, Traditional Microbiology
Speaker
Dr. Andreas Bubert
Merck
Senior Product Manager

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Short Webinar: Regulatory Compliance of Culture Media Based Detection of Pathogens

Subcategory: Industrial Microbiology Misc.
Duration: 10 minutes

This 10-minute talk focuses on ISO regulations for the detection of the most important pathogen, Salmonella spp., in the food chain and describes how the regulatory compliance for the required culture media can be made transparent for laboratories.

Speaker:
Speaker
Dr. Andreas Bubert
Merck
Senior Product Manager
 
 
 
 

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Environmental Monitoring in Aseptic Manufacturing - Regulatory Requirements for Culture Media and Validation

Subcategory: Industrial Microbiology Misc.
Duration: 60 minutes
Presented: 29 November, 2018

The webinar will cover the various GMP guidance, ISO Norms or pharmacopoeia regulatory demands for environmental monitoring culture media used in aseptic areas.

Abstract:
Environmental monitoring of air, surfaces and personnel in aseptic areas can be complex, particularly in terms of culture media and regulatory requirements including GMP, ISO norms and pharmacopoeia. Join our on-demand webinar to see how we can help guide you through. Topics covered include:
  • Selection criteria of media formulation regarding their growth properties
  • Formulation selection based on probable antimicrobial residues at the sampling point
  • Supplier validation of culture media
Speakers:
Speaker
Dr. Anne-Grit Klees
Merck
Global Product Manager, Environmental Monitoring
Speaker
Gisela Stark-Reinhart
Merck
Global Product Manager, Environmental Monitoring

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Hygiene Monitoring Impact of Disinfectants on ATP results

Subcategory: Industrial Microbiology Misc.
Duration: 60 minutes
Presented: 29 October, 2018

We provided a scientific comparison study, to see how different sample devices react to the main sanitizers used in Food and Beverage industry.

Abstract:
ATP testing is being used by many Food & Beverage companies to verify the efficiency of their cleaning procedure. The amount of ATP is measured by the bioluminescence reaction (luciferin + luciferase). Some chemical compounds, including detergents, can affect the light signal of this reaction. Therefore, the presence of disinfectant residues on surfaces can have a negative impact on the reading and lead to false negative results. We provided a scientific comparison study, to see how different sample devices react to the main sanitizers used in Food and Beverage industry.

Other than that we will be pleased to introduce some projects our innovation center is working on:
  • Clean meat: an innovation that focuses on the biotechnology required to produce genuine meat grown in vitro
  • Is it fresh: a collaboration with a start-up company that makes packaging smart enough to indicate if the food is still fresh.
Speakers:
Speaker
Adèle Gisselmann
Merck
Global Product Manager, Hygiene Monitoring in Food & Beverage
Speaker
Charlotte Lindhardt
Merck
Senior Validation Expert
Speaker
Tobias Weitzel
Merck
Head of Operations, Innovation Center
 
 
 
 

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Spoilage and Sterility Tests in Beverages: New Revised IFU Method No. 12 for Detection of Alicyclobacillus in Fruit Juices, and Sterility Testing of Aseptic Filling Lines

Subcategory: Industrial Microbiology Misc.
Duration: 60 minutes
Presented: 29 November, 2018

This webinar explains the new revised IFU Method No. 12 from 2019 for detection of Alicyclobacillus spp. in fruit juices and provides information about validation of aseptic filling lines in beverage production.

Abstract:
Alicyclobacillus spp. can be difficult to control in fruit juice products as their spores survive juice pasteurization temperatures and may germinate and grow after processing if conditions are suitable. The economic impact of such incidents can be very high. The International Fruit and Vegetable Juice Association (IFU) Microbiological Working Group has revised, improved and validated their worldwide accepted method for the detection of Alicyclobacillus spp. in fruit juices with improved culture media formulations including performance criteria which are in agreement with ISO procedures.

For aseptic validation of filling lines, Sidel microbiological validations are carried out in two subsequent phases. The first takes place on Sidel premises to ensure the decontamination efficiency of the sterilization applied to packaging, while the second is carried out on the complete line installed at the customer site to ensure the commercial sterility of the filled product. Depending on the client's product, different microbiological broths for low acid (pH > 4.6) or high acid (pH ≤ 4.6) applications are useful.

Speakers:
Speaker
Barbara Gerten
Merck
Application Training Scientist, Traditional Microbiology
Speaker
Dr. Andreas Bubert
Merck
Senior Product Manager
Speaker
Dr.-Ing. Andreas Politzer
ADM WILD Europe GmbH & Co. KG, Eppelheim, Germany
Senior Manager,
Microbiology & Food Safety
Speaker
Dr. Silvia Garulli
Sidel, Parma, Italy
Microbiology Laboratory Manager

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In-Vitro Pyrogen Detection, the New Trend

Subcategory: Industrial Microbiology Misc.
Duration: 60 minutes
Presented: 25 October, 2018

The new PyroMAT™ System provides pharma companies with a robust solution to make the move to in vitro Pyrogen Test with a ready-to use kit.

Abstract:
For pharmaceutical companies, patient safety has always been the priority. That's why pyrogen detection has become a mandatory Quality Control test for release of any parenteral drug.

With the Monocyte Activation Test, the only in vitro test for the detection of the full range of pyrogens (including endotoxin and Non Endotoxin Pyrogens), it's now time to move away from animal-based test for pyrogen detection.

The new PyroMAT™ System provides pharma companies with a robust solution to make the move to in vitro Pyrogen Test with a ready-to use kit!

What You Will Learn:
  • The current status of pyrogen detection methods
  • Benefits of the monocyte activation test (MAT) and how to use it
  • Validation of the PyroMAT™ System
  • Real life case study using the PyroMAT™ system
Speakers:
Speaker
Laure Robert
Merck
Global Product Manager
Speaker
Anja Fritsch
Confarma, France
Chief Scientific Officer

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Revised ISO 11133 and ISO16649 Food Microbiology Standards: How this Affects Your Lab

Subcategory: Industrial Microbiology Misc.
Duration: 60 minutes

This webinar explains the amendments of the ISO 11133:2014 and the revised ISO 16649 part 1:2018 for enumeration of Escherichia coli in the food chain.

Abstract:
ISO 11133:2014 is a mandatory standard for all ISO 17025-accredited labs for microbiological analysis of food, feed and water. It describes the preparation, production and performance testing of culture media from this whole area. Recently published amendment 1:2018 contains corrections and additional explanations whilst future amendment 2 will describe the performance testing of confirmation media and reagents.

ISO 16649-1, which specifies a horizontal method for the enumeration of β-glucuronidase-positive Escherichia coli, has also been revised. The method uses a colony-count technique after resuscitation using membranes and incubation at 44 °C on TBX agar. There are three horizontal methods (ISO 16649-1, ISO 16649-2 and ISO 16649-3) for the enumeration of β-glucuronidase-positive Escherichia coli, all parts are for general application. Parts 1 and 3 include a resuscitation step and should be used in preference for foodstuffs likely to contain sub-lethally injured cells.

This webinar explains the latest changes in ISO 11133 and ISO 16649 and will give an outlook on the future of both standards.

Speakers:
Speaker
Barbara Gerten
Merck
Application Training Scientist, Traditional Microbiology
Speaker
Dr. Andreas Bubert
Merck
Senior Product Manager

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Convenient Media: A Reliable Alternative to Traditional Methods?

Subcategory: Industrial Microbiology Misc.
Duration: 60 minutes
Presented: 27 September, 2018

In this webinar, we will discuss how these alternative methods can change your workflow, we will analyze their performance, with a particular focus on difficult matrices.

Abstract:
Your microbial testing workflow is reliant upon your choice of culture media, not only in terms of storage and handling, but more importantly, can you trust the results? Many new culture media products have recently entered the market, so choosing the right one can be tricky. Are convenient culture media products a reliable alternative to traditional methods? In this webinar, we will discuss how these alternative methods can change your workflow, we will analyze their performance, with a particular focus on difficult matrices.

Speakers:
Speaker
Anke Hossfeld
Merck
Global Product Manager
Speaker
Scott Medley
Merck
Global Product Manager

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Industry Trends in Aseptic Simulation

Subcategory: Industrial Microbiology Misc.

The media fill test is one critical component of the aseptic process simulation.

This webinar will:
  • Define the criteria to be considered when validating and implementing a media fill test, as well as how to interpret and react to the results
  • Discuss considerations for fill and container, media types, as well as environmental monitoring sampling criteria
  • Explore new data on current practices and participate in a discussion on industry trends for media fill design criteria, and broad usage of guidances when looking to comply with regulatory expectations
Speaker:
Scott Sutton
Scott Sutton
Merck
Ph.D., Principal of Microbiology
 
 
 
 

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Essential Components for Implementation of a Robust Environmental Monitoring Program

Subcategory: Industrial Microbiology Misc.

This webinar pieces together the essential components and best practices for successful implementation of an environmental monitoring program.

Key learning points for this webinar:
  • Understand the essentials of a robust risk based Environmental Monitoring program.
  • Learn about the importance of ISO 14698 when selecting air sampling instrumentation
  • Discover the value in using products designed to work together to ensure optimal recovery with results you can trust
Speakers:
Tim Sandle, Ph.D.
Tim Sandle, Ph.D.
Bio Products Laboratory
Head of Microbiology
Anne Connors
Anne Connors
Merck
Regional Product Manager

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What's Bugging you about Bioburden and Sterility Testing

Subcategory: Industrial Microbiology Misc.

In this webinar you will learn how a deeper understanding of membrane filtration can help with method development for bioburden and sterility testing.

Key learning points for this webinar:
  • How a deeper understanding of membrane filtration can help with method development for bioburden and sterility testing
  • How to optimize membrane filtration for different samples
  • Tips and tricks for membrane filtration method development
Speakers:
Shari Spector
Shari Spector
Merck
Field Marketing Manager
Cheryl Platco
Cheryl Platco
Merck and Co.
Guest Speaker
Beth Brescia
Beth Brescia
Merck
 
Judith Eycleshymer
Judith Eycleshymer
Merck
 

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The Whole Blood Assay: Detection of Broad Spectrum of Pyrogens and Examples of Medical Device Testing

Subcategory: Industrial Microbiology Misc.

In this webinar you will learn how Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies endotoxins, while the rabbit pyrogen test (RPT) endangers animals. Fortunately, the MAT (Monocyte-Activation Tests) alternative covers a much broader range of pyrogens and is completely animal-free. In our insightful webinar you will get a closer look at the whole blood assay, non-endotoxin pyrogens detection, and pyrogen testing in medical devices.

Speaker:
Dr. Thomas Hartung
Dr. Thomas Hartung
Thomas Hartung, MD PhD, is Professor of Toxicology, Pharmacology, Molecular Microbiology and Immunology at Johns Hopkins Bloomberg School of Public Health, Baltimore, and University of Konstanz, Germany; he also is Director of their Centers for Alternatives to Animal Testing (CAAT)

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Media Fill Tests: Vegetable Peptone Alternatives and Filterability

Subcategory: Industrial Microbiology Misc.

A comprehensive comparison study provided by culture media manufacturers can help to reduce the effort for internal validation. An example of such a study will be discussed.

Abstract:
Soybean Casein Digest Medium (SCDM) or Tryptic Soy Broth (TSB) is the only medium for aerobic media fill which is mentioned with formulation in international Pharmacopeias. Yet, the risk of contaminations with Transmissible Spongiform Encephalopathies and the documentation effort involved have caused the use of media with alternative, vegetable peptones to become more and more popular in recent years. These Vegetable Peptone Broths require a validation to prove equivalence with standard TSB.

One of the most frequent issues related to the use of dehydrated culture media for aseptic filling process simulations is filterability, especially challenging with Vegetable Peptone Broth. A recently conducted comparison study of the most relevant dehydrated media fill broths commercially available reveals considerable differences between both the media and the filter types commonly used for this application.

Speaker:
Volker Lanz
Volker Lanz
Merck
Global Product Manager Core Products, BioMonitoring
 
 
 
 

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Cleanroom and Isolator Instrumentation: Best Practices

Subcategory: Industrial Microbiology Misc.

A comprehensive comparison study provided by culture media manufacturers can help to reduce the effort for internal validation. An example of such a study will be discussed.

Abstract:
Choosing and implementing your environmental monitoring instruments is critical for a safe production and continued compliance. Ensure optimum performance from your microbial environmental monitoring in aseptic manufacturing processes in cleanrooms and isolators. Merck can support the quick implementation of specifically designed and validated products along with the reliable tests to be fully compliant with current regulations. We provide a high level of expertise and good practices on both applications and equipment used within quality control laboratories. We have gained the regulatory and technological know-how to offer you a comprehensive range of best-in-class equipment and professional services.

Speaker:
Tony Ancrum
Tony Ancrum
Merck
Global Product Manager, Environmental Monitoring
 
 
 
 

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Revised ISO Food Microbiology Standards for Detection of Listeria, Enterobacteriaceae and Cronobacter

Subcategory: Industrial Microbiology Misc.

How can you stay ISO certified in the current environment of an ever-increasing, but necessary regulation?

Abstract:
The ISO food microbiology standards are changing for ISO 11290, ISO 21528, and ISO 22964. All food products and ingredients intended for human consumption and the feeding of animals are implicated, along with environmental samples in food production and handling areas. Our food microbiology expert, member of the German ISO delegation, will guide you through the most recent changes for handling the testing of Listeria (ISO 11290), Enterobacteriaceae (ISO 21528), and Cronobacter (ISO 22964) to help you remain compliant.

Speakers:
Speaker
Barbara Gerten
Merck
Application Training Scientist, Traditional Microbiology
Speaker
Dr. Andreas Bubert
Merck
Senior Product Manager

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Pharma/Biopharma Manufacturing

Browse subcategory:

Subcategory: Biopharm Services and Solutions

Securing Your Cell Banks: Embracing Closed System Technologies for EU GMP Annex 1 Compliance

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 29 August, 2024

In this webinar, you will learn:
  • What a ‘traditional’ cell bank manufacturing looks like, and how it compares to the ‘Closed System Manufacturing’
  • How our custom process and designs integrate to create an all-encompassing closed system production in line with Annex 1 compliance
  • How we quantify the number of times we open and close your growth vessels to reduce risk
  • Our development runs and results, and what they mean for your manufacture
  • About how our integrated electronic laboratory notebooks (ELNs) ensure accuracy throughout the production
Detailed description:
Annex 1 of the European Union's (EU) Good Manufacturing Practice (GMP) guidelines emphasizes the importance of closed system processing in pharmaceutical manufacturing, by accomplishing material transfer via aseptic connections of auxiliary materials and equipment. The guidelines also address the design, construction, integrity, sterility, validation, monitoring, and control of closed systems to ensure aseptic conditions and minimize the risk of contamination. Join us to explore how our cell bank manufacturing service is striving to establish a closed manufacturing process, detailing the development of our two-phase approach which promises the most reliable process to date to meet Annex 1 expectations.

Speaker:
Speaker
Angela Waugh
Merck
Global Scientific Lead, Manufacturing Value Stream
Speaker
Jorge ‘Steven’ Acuna
Merck
Senior Process Engineer

The Road to Approval: Viral Clearance Strategies for Non-Enveloped Viral Vectors

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 20 June, 2024

In this webinar, you will learn:
  • How to identify the sources of potential viral contaminants and develop steps in the manufacturing process to selectively remove or inactivate them
  • Why a viral clearance study for viral vector may evaluate fewer steps than a study for a monoclonal antibody or recombinant protein
  • The existing principles for evaluation of inactivation, filtration and chromatography steps apply to a clearance evaluation for a viral vector product
Detailed Description:
The updated ICH Q5A(R2) guideline incorporates viral vectors in its viral safety guidance, including the expectation for a viral clearance study for non-enveloped viral vectors. Designing a viral clearance study for a non-enveloped viral vector requires thoughtful consideration of the risk of any adventitious, endogenous or production viruses that might be present as a potential contaminant. Viral clearance steps should be implemented in the manufacturing process that will selectively inactivate or remove potential contaminants without any detrimental impact to the vector. A well-designed viral clearance study will contribute to the assurance of a vector’s overall viral safety on your journey to regulatory approval.

Speaker:
Katie Schewe
Kathryn Remington, Ph.D.
Merck
Technical Consultant, Technical and Scientific Solutions
 
 
 
 

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Make More Lentivirus and Make it Right the First Time

Subcategory: Biopharm Services and Solutions
Duration: 39 minutes
Date: 6 June, 2024

In this webinar, you will discover how our comprehensive lentivirus platform enables clinical and commercial success by:
  • Accelerating timelines
  • Achieving higher titers and quality per batch
  • Conserving your time and resources
Detailed Description:
Embrace higher titers and robust yield. Our optimized, end-to-end VirusExpress® lentivirus platform delivering maximized production and quality outcomes to enable the success for your cell or gene therapy. Benefit from accelerated development timelines, de-risked manufacturing, and achieve the performance and product quality critical for clinical trials, all while delivering a lower cost per therapeutic dose.

Speaker:
Katie Schewe
Katie Schewe
Merck
Business Account Manager
 
 
 
 

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To Target or Not to Target: NGS Applications for Biosafety Testing

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 23 April, 2024

In this webinar, you will learn about:
  • Regulatory landscape and changing approach to adventitious agent testing
  • Role of targeted vs non-targeted NGS
  • Case studies to demonstrate the application of NGS for AAT detection
Detailed Description:
There is an evolution of new molecular technologies and a responsibility to incorporate alternate technologies for the detection of adventitious agents. NGS has emerged as a key method that may be used to detect virus contamination throughout the development of biologics products. In the recent revision of the ICH Q5A guidance the replacement of in vivo, in vitro and species-specific applications with NGS has been discussed and the terms, targeted and non-targeted NGS, were introduced.

Within this webinar, the definition of NGS applications, their applications and specific case studies will be presented to support use of this core technology as part of risk assessment of biologics products.

Speakers:
Speaker
Alison Armstrong, Ph.D.
Merck
Sr. Director, Technical and Scientific Solutions
Speaker
Manjula Aysola
Merck
Senior Regulatory Consultant

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Solving Synthesis Challenges: Small Molecule CTDMO Strategies

Subcategory: Biopharm Services and Solutions
Duration: 1 hour, 45 minutes
Date: 22 February, 2024

In this technical symposium, industry experts will present about:
  • Tech transfer methodology to ensure success of your first GMP batch
  • Strategic planning through a phase appropriate quality approach
  • Case study on overcoming obstacles during the journey to bring new medicines to patients
  • How to use small molecule payloads and advanced intermediates to accelerate development of ADC therapies
Detailed Description:
Embark on your small molecule drug development journey with advice from industry experts. Navigate the intricacies of developing, synthesizing, and sourcing across a wide range of segments such as HPAPIs, APIs, Next-Generation Conjugates, Linker-Payloads, PEGs, and Targeted Protein Degradation. 

In this symposium, learn tech transfer approaches to ensure your first GMP batch is right first time, master how to deploy phase appropriate quality for efficiencies in your drug development process, explore a case study in overcoming obstacles along the journey to commercialization, and examine how our small molecule offer can accelerate your ADC therapies. Unlock the secrets to seamless small molecule contract development and manufacturing with Millipore® CTDMO Services.

Two Speakers:
Speaker
Ross Bemowski
Merck
Associate Director, API R&D
Speaker
Matt Dodge
Merck
Head of Client Project Management
Speaker
Angela Masino
Merck
Associate Director, API R&D
Speaker
Jason Modest
Merck
Director of Manufacturing, Science and Technology
Speaker
Kyle Loehr
Merck
Head of Sales, ADC and Small Molecule
Speaker
John Stevens
Merck
Field Marketing Manager

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mRNA - Powering Life Changing Therapies

Subcategory: Biopharm Services and Solutions
Duration: 1 hour, 27 Minutes
Date: 12 October, 2023

In this technical symposium, industry experts will be presenting about:
  • Key factors for a robust mRNA manufacturing through next generation PCR-based workflow
  • Analytical development and product characterization for mRNA vaccines and therapeutics
  • Improving the performance of self-replicating RNA
Detailed description:
The mRNA landscape is rapidly evolving, unfolding opportunities to bring life changing therapies to patients and overcome process and analytical challenges on the journey of mRNA-based drugs to market.

Join industry experts to learn about strategies to accelerate mRNA therapies and enable scalability and process efficiency from preclinical to commercial. Get an overview of our integrated CTDMO offering, our newly launched mRNA Center of Excellence for robust mRNA manufacturing and our services for analytical development and product characterization.

Two Speakers:
Speaker
Andrew Geall, Ph.D.
Merck
Chief Development Officer, Replicate Bioscience
Speaker
Conner Feldman
Merck
Strategy Manager, Emerging Modalities
Speaker
Jason Sterling, Ph.D.
Merck
Global Business Lead, Product Characterization
Speaker
Bastian Rouven Brückner, Ph.D.
Merck
Head of Operations
Speaker
Aditi Mehta, Ph.D.
Merck
Moderator, Associate Director, Head of mRNA Process & Delivery
 
 
 
 

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Scaling for Commercialization: Considerations for Large-Scale API Production

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 14 September, 2023

In this webinar, you will learn:
  • Process optimizations and efficiencies at commercial scale
  • Production scalability, from lab to plant
  • Regulatory considerations for clinical and commercial filings
Detailed description:
As programs progress through the clinic and require scaling to larger batch sizes, a seasoned commercial partner is critical for program success. Key considerations such as risk mitigation, production scalability, regulatory filing support, and specialized technological capabilities should be thoroughly evaluated.

In this webinar, we take a look inside our latest capacity expansion for large-scale GMP API production located in Darmstadt, Germany. With a commitment to phase appropriate quality, flexibility, and sustainability the right CTDMO partner can help navigate the complexities of large scale programs.

Speakers:
Speaker
Bertram Cezanne, Ph.D.
Merck
Department Head of Process Development
Speaker
Bertram Barnickel, Ph.D.
Merck
Director, Head of Value Stream Management
Speaker
Ulrich Reichert, Ph.D.
Merck
Head of CDMO and Bioprocess Materials, Regulatory Management
Speaker
Bertram Barnickel, Ph.D.
Merck
Moderator, Strategic Marketing Manager

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What's Really in the Box? Characterizing AAV Encapsidated Nucleic Acid Sequences Using NGS

Subcategory: Biopharm Services and Solutions
Duration: 30 minutes
Date: 22 June, 2023

In this webinar, we will explore:
  • How NGS can provide broad characterization of targeted and non-targeted sequences packaged in an AAV particle
  • The process for evaluating encapsidated residual sequences in an AAV sample
  • Concepts for the determination of nucleic acid content of full, partial, and empty capsids
Detailed description:
Due to the nature of AAV particle production, non-targeted sequences may be packaged along with the gene of interest. Even in an optimized system, these non-target nucleic acids can comprise between 1-2% or greater of the entire nucleic acid payload. Characterizing the non-targeted sequences that may be packaged in the vector is important for establishing the safety profile of the final product.

NGS can provide a clearer picture of all encapsidated sequences within the AAV particles. In this webinar, we discuss characterization of several representative AAV molecules using NGS, including the sequencing process, bioinformatic analysis, and representative results.

Speakers:
Speaker
Bradley Hasson
Merck
Director of Lab Operations for NGS Services
 
 
 
 

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Building Better Degraders: Targeted Protein Degradation Partners from Lead Discovery to Production

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 15 June, 2023

In this webinar, you will learn about:
  • Targeted Protein Degradation (TPD) technologies
  • A mechanistic view of this new modality
  • Chemical advancements for modular and strategic degrader design
  • How to select the appropriate contract manufacturing partner
Detailed description:
Targeted Protein Degradation (TPD) has created a paradigm shift and emerged as a front runner in drugging many "undruggable" targets. As a new modality, it poses unique challenges for lead discovery as well as API development and manufacturing.

We will focus on the latest advances in chemical building blocks for protein degradation, including warheads, linkers, and ligands, and how they can be used to build better degraders. Once a candidate has been identified, selection of the right CDMO can take a phase appropriate approach to develop with commercial readiness in mind, provide partnered quality & regulatory support, and offer batch scalability as you progress through the clinic.

Speakers:
Speaker
Aditya S. Vaidya
Merck
Senior Scientist, Chemical Biology Innovation
Speaker
Hugo Matos Viana
Merck
Global Product Manager - Chemical Biology
Speaker
Jacqueline Ruff - Moderator
Merck
Strategic Marketing Manager
Speaker
Jason Modest
Merck
Director of Manufacturing, Science and Technology

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Transforming the Biopharma Supply Chain, eData Solutions for Agility and Manufacturing Efficiency

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 1 June, 2023

In this webinar, you will learn:
  • Key benefits of electronic data exchange collaboration
  • Use cases and applications for digitalization improvements
  • Advantages of a standard platform for eData exchange
  • Key success factors for implementation
  • How to become a collaborating partner
Detailed description:
Transforming the BioPharma supply chain to future ready requires digital technologies. A digital supply chain and access to real-time data enables process improvements and proactive logistical responses to mitigate supply disruptions.

This webinar will discuss how eData enables process automation and simplification, including critical analytics and logistics data from suppliers of raw materials and production consumables. How integration of logistical eData is key to developing predictive analytics and to improve resilience. Also discussed is next steps to a industry-wide eData solution and how manufacturers can adopt a standardized digital platform.

Speakers:
Speaker
Chang Ge
Merck
Product Manager, Logistical Services
Speaker
Prithwiraj (Prith) Das
Merck
Manager, Customer Success, Analytical & Logistical Services

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Who Counts as an Expert? Establishing Analytical Methods for Emerging mRNA-based Therapies

Subcategory: Biopharm Services and Solutions
Duration: 45 minutes
Date: 25 May, 2023

In this webinar, we will explore::
  • toolbox of methods to support mRNA products, comprising a combination of off-the-shelf assays and product-specific methods
  • The power of Next Generation Sequencing to detect potential issues
  • The deployment of GMP-compliant LC-MS to support activities from analytical development through to QC
  • The use of UHPLC with Charged Aerosol Detection for the analysis challenging analytes, such as mixtures of lipids in an LNP
Detailed description:
The success of the first vaccines for SARS-CoV-2 demonstrated both the effectiveness of mRNA technology and the speed at which new vaccines could be developed using such a platform.

The sudden emergence of this novel modality has necessitated the rapid development of analytical methodologies to ensure product quality and meet the evolving regulatory requirements. This challenge is further complicated by the different nature of mRNA drug substance and the formulated drug product, often in the form of a lipid nanoparticle (LNP). In this webinar, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substance and drug product.

Speakers:
Speaker
Martin De Cecco, Ph.D.
Merck
Technology Lead, Product Characterization
Speaker
Amy Glekas, Ph.D.
Merck
Global Business Lead, NGS and Novel Modalities

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Key Benefits of PCR-based mRNA Manufacturing for Clinical Development

Subcategory: Biopharm Services and Solutions
Duration: 39 minutes
Date: 16 May, 2023

In this webinar, you will learn:
  • Which key parameters impact mRNA manufacturing speed, capacities as well as quality
  • Understand the benefits of our flexible GMP mRNA manufacturing platform for clinical and commercial mRNA demands
  • How our innovative PCR-based process can accelerate your mRNA development and manufacturing program
  • mRNA CDMO Services as part of our highly connected network to ensure speed, scalability, quality and flexibility for mRNA, lipid, LNP formulation and Fill & Finish
Detailed description:
To unlock the potential of your mRNA therapies and accelerate your mRNA development and manufacturing program, discover the benefits of our novel PCR-based mRNA drug substance manufacturing process. With this innovative and flexible process, we can provide mRNA at all scales and qualities for all stages of a mRNA program life cycle, from pre-clinical to commercial.

Learn about our truly integrated mRNA-LNP CDMO offering, and how we can support you as the single-source partner along all critical steps from mRNA drug substance manufacturing, through lipids and lipid nanoparticle (LNPs) to fill & finish of the final drug product.

Speakers:
Speaker
Julian Mochayedi, Ph.D.
Merck
Strategic Marketing Manager for mRNA Solutions
Speaker
Eike Joest, Ph.D.
Merck
Global Business Lead, NGS and Novel Modalities

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Streamlining Viral Vector Development and Manufacturing for Gene Therapies

Subcategory: Biopharm Services and Solutions
Duration: 42 minutes
Date: 11 May, 2023

In this webinar, you will:
  • Hear from our team of viral vector experts about our capabilities and solutions
  • Discover how we support your gene therapy from preclinical to commercial production in a single facility
  • Take a virtual tour of our state-of-the-art GMP manufacturing facility
Detailed description:
As clinical success, innovation and investment in cell and gene therapy grows, emerging therapies are targeting more chronic conditions and cancers, in addition to rare diseases. This makes viral vector manufacturing—a critical component in gene and cell therapy— in demand. As more biopharma innovators focus on developing new therapies, many are choosing to partner with a CDMO that can support them from preclinical through commercialization.

Join our viral vector experts to learn more about our capabilities and solutions for gene therapy production as they highlight key features of our technologies and infrastructure through a virtual tour of the GMP manufacturing facility.

Speakers:
Speaker
Julian Mochayedi, Ph.D.
Merck
Sr. Manufacturing Manager
Speaker
James Turner
Merck
Upstream Manufacturing Supervisor
Speaker
Jason Rodriguez
Merck
Downstream Manufacturing Supervisor
 
 
 
 

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Advancements in Process and Payload Development for ADCs and Next-Generation Bioconjugates

Subcategory: Biopharm Services and Solutions
Duration: 1 hour, 38 minutes
Date: 27 April, 2023

In these Tech Talks you will learn from our experts about:
  • Challenges and solutions to adapt processes to next-generation conjugates
  • Application of process analytical technology (PAT) in bioconjugation processes
  • Solubility enhancement for traditional and novel hydrophobic payloads
  • ADCore intermediates to deliver rapid access to linker-payloads
Detailed description:
We invite you to a series of presentations on process and payload innovation for ADCs and bioconjugates. As an established CDMO, we will share insight on adapting conjugation processes and analytics to non-traditional ADCs and highlight the integration of PAT into development and manufacturing. Also bringing focus to linker-payloads, we will discuss accelerated strategies to access and solubilize drug linkers. Together, these templates and technologies will continue to help ADC developers confidently bring novel therapies to patients.

Speakers:
Speaker
Melissa Ritchie
Merck
Senior Scientist, Analytical Development
Speaker
Sowmyan Sreenivasaraghavan
Merck
Scientist, ADC Process Development
Speaker
Haowei Song
Merck
Principal Scientist in Novel Modalities R&D
Speaker
Jake Spies
Merck
Senior Scientist Group Lead Process & Analytical Development
Speaker
Ross Bemowski
Merck
Associate Director, API R&D
Speaker
Kaelyn Wilke
Merck
Associate Director, ADC & Bioconjugation Services

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Maximizing the Value of your AAV Using Small Volume AAV Testing

Subcategory: Biopharm Services and Solutions
Duration: 30 minutes
Date: 25 April, 2023

In this webinar, you will learn:
  • Key considerations for determining your AAV therapy's critical quality attributes aligned with regulatory guidance
  • Strategic orthogonal assays to confirm product identity and purity that conserve precious amounts of AAV material from your production batches
Detailed description:
Analyzing recombinant Adeno-Associated Virus (rAAV) can be challenging as significant portions of process development and clinical trial material batches are consumed during the measurement of critical quality attributes (CQAs). However, measuring specific rAAV CQAs such as identity and purity is an essential part of gaining process understanding, developing control strategies, and mitigating the risks associated with an AAV drug program.

Join this webinar to learn our approach to method development where we can measure more than one AAV CQA within a single analytical run. This small volume AAV testing package reduces the amount of test material required so you can treat more patients.

Speaker:
Speaker
Jason Sterling, Ph. D.
Merck
Global Business Lead, Product Characterization
 
 
 
 

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Client Case Study: How an Optimized Purification Platform Can Speed mAbs Clinical Production

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 23 March, 2023

In this webinar, you will learn how a process platform can help:
  • Accelerate your development journey
  • Facilitate transfer and scale-up to production
  • Gain knowledge on the molecule
Detailed description:
Getting your antibody to clinical trials faster while being able to build a robust, scalable, and high-yielding process is a challenge many biotech companies face. By outsourcing to a CTDMO, you can benefit from an optimized platform process. In this webinar, we will showcase our purification development platform, including an MMC* step and how it allowed our client Igyxos Biotherapeutics to simplify and accelerate their clinical trial supply while achieving high-quality material.

*mixed-mode chromatography

Speakers:
Speaker
Marie Cecille
Merck
Technical Leader
Speaker
Thierry Ziegler
Merck
Chief Operation Officer

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Custom LNP Formulation Development - The new Early Formulation Screening Service as a Key Partner for Success

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 15 December, 2022

In this webinar, you will learn:
  • How to overcome obstacles in lipid nanoparticle formulation development
  • Key considerations for process and analytical development of lipid nanoparticles
  • About case studies highlighting customized lipid nanoparticle formulations that are ready to be transferred to clinical and commercial drug product development
Detailed description:
Nucleic acids are known to be fragile payloads. To enable their safe and efficient delivery into cells, the RNA payload needs to be “packed” into a delivery vehicle, the lipid nanoparticles (LNP). This webinar gives insight into our capabilities for customized LNP formulation development for novel therapeutic modalities. The manufacturing, optimization, analytical characterization, in vivo testing, and scale-up strategy for LNP will be discussed.

With our newly launched service, we aim at simplifying the road to market, by providing preclinical development service, delivering animal trial material (including for GLP tox studies) and supporting in-house transfer to clinical GMP manufacturing.

Speakers:
Speaker
Johanna Simon, Ph.D.
Merck
Principial Scientist
 
 
 
 

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From Discovery to Market Readiness, CTDMO Services as an Enabler

Subcategory: Biopharm Services and Solutions
Duration: 30 minutes
Date: 13 December, 2022

In this webinar, you will learn:
  • Our commercial production facility’s capacity and capabilities
  • The importance of tech transfer for market readiness
  • The impact of harmonized single-use equipment on faster validation
Detailed description:
In the earliest phases of biologics development, biotech companies are challenged to move fast while generating data on their lead molecule and its manufacturability. How do you make sure that your process data don’t get lost in translation between clinical and commercial manufacturing?

In this webinar, we will present how our mAbs CTDMO* Services can be an enabler for innovators to successfully bring their molecule to market with the advantages of in-house testing, harmonized single-use equipment and integrated raw material supply.

*Contract Testing, Development, and Manufacturing Organization

Speakers:
Speaker
Jean François Michel
Merck
Head of Commercial Manufacturing, Life Science Services
Speaker
Jean-Baptiste Noirot-Cosson
Merck
Head of Manufacturing Science and Technology, Life Science Services

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Characterization of Monoclonal Antibodies and Antibody Drug Conjugates by Surface Plasmon Resonance

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 8 December, 2022

Highlights of this webinar:
  • Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs
  • SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations
  • Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies
  • The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process
Detailed description:
Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life.

An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.

Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs.

Speakers:
Speaker
Helen Hsu, Ph.D.
Merck
Principal Scientist, Process and Analytical Development
 
 
 
 

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Going Viral: Process and Facility Design Considerations for CGT Manufacturing

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 8 November, 2022

In this webinar, you will learn:
  • Key differences in viral vector vs. other biologics manufacturing processes
  • How these differences translate to facility layout
  • How to develop a strategy to increase your long-term business value
Detailed description:
Viral Vector therapies are gaining increasing traction with more and more companies looking to take the leap from other Biologics. In the early stages of clinical development, it’s expedient to outsource to de-risk the venture. For CGTs, this can be challenging because CDMO capacity is limited and the manufacturing complexity is higher than for other biologics. Nevertheless, experience in bioprocessing can be leveraged.

Understanding the similarities and differences between CGT and other biologics processes is crucial to design a facility. Comparisons will be made between mAb and viral vector facility layouts. Based on this, considerations for your strategy development will be explored.

Speakers:
Speaker
David Loong, Ph.D.
Merck
Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Speaker
Ina Bhartia
Merck
Senior Strategy Manager
Steve Maina
Steve Maina
Merck
Director of Advisory Services
 
 
 
 

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A Rapid, Innovative Approach to Release Testing with Blazar® CHO AOF Virus Panel

Subcategory: Biopharm Services and Solutions
Duration: 45 minutes
Date: 13 October, 2022

In this webinar, we will introduce the Blazar® CHO AOF assay and discuss:
  • Application of a degenerate PCR-based method to accelerate bulk harvest testing
  • Virus coverage of the assay
  • Comparability to traditional methods of virus testing, including faster time to results
Detailed description:
Innovative molecular methods will allow mAbs manufacturers to deliver critical therapeutic agents to patients faster. The Blazar® CHO AOF virus panel is a powerful tool to accelerate bulk harvest testing with the potential to replace slower culture-based in vitro virus detection methods. It is a degenerate PCR-based assay for broad detection of adventitious agents in materials grown with animal origin free (AOF) media and reagents. A degenerate primer approach allows for broader coverage than traditional PCR. Blazar® degenerate primers are designed to target specific viral risks while detecting related viral variants and newly emerging viruses.

Speakers:
Speaker
Mohammad Heydarian. Ph.D.
Merck
Principal Scientist
 
 
 
 

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Key quality Attributes for mRNA Drug Substance Performance - Considerations and Best Practices

Subcategory: Biopharm Services and Solutions
Duration: 53 minutes
Date: 1 September, 2022

In this webinar, we will learn:
  • How the mRNA based therapeutics pipeline is rapidly evolving
  • About key quality attributes and associated analytics for successful mRNA therapeutic applications
  • How our PCR-based technology can accelarate your mRNA development and manufacturing program
Detailed description:
mRNA-therapeutics have become the most discussed and growing modality in recent years. While COVID vaccine development occurred in record time, critical design and quality attributes must be considered when developing mRNA for other therapeutic applications.

This presentation covers the key quality attributes and analytics impacting mRNA performance, including best practices to ensure success. Furthermore, we discuss how our unique PCR-based mRNA CDMO Service technology can accelerate mRNA development and manufacturing for our customers.

Speakers:
Speaker
Julian Mochayedi, Ph.D.
Merck
Strategic Marketing Manager for mRNA Solutions
Speaker
Christof Trabszo, Ph.D.
Merck
Head of Quality Control

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Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Landscape

Subcategory: Biopharm Services and Solutions
Duration: 53 minutes
Date: 28 July, 2022

In this webinar, we will answer:
  • Which regulatory guidelines do you need to comply for your INDs?
  • When do you start implementing GMPs and validated assays?
  • How do you get your QC testing strategy ‘right the first time’?
  • How do you ensure testing is not your rate limiting step for the IND submission?
Detailed description:
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.

Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.

Speakers:
Speaker
Manjula Aysola
Merck
Senior Regulatory Consultant
Speaker
Christof Trabszo, Ph.D.
Merck
Sr. Director, Technical and Scientific Solutions

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Identity testing by NGS as a means of risk mitigation for viral gene therapies

Subcategory: Biopharm Services and Solutions
Duration: 45 minutes
Date: 19 July, 2022

In this webinar, we will explore:
  • Regulatory requirements for identity testing
  • NGS applications for identity testing as compared to traditional methods
  • A case study on the impact of not establishing a proper risk-based testing strategy
Detailed description:
Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented.

The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources. Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches.

Speakers:
Speaker
Bradley Hasson
Merck
Director of Lab Operations for NGS Services
 
 
 
 

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Balancing Risk, Speed and Cost in Biopharmaceutical Process Development & Manufacturing

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 16 June, 2022

In this webinar, you will learn:
  • Strategies used and activities performed to achieve high-concentration formulation to address client’s testing needs
  • Analytical and process development strategies that reduce the time required to produce biologics, while balancing risk and cost
Detailed description:
Biotech organizations can encounter a variety of challenges, both expected and unexpected, during biopharmaceutical development. Anticipating and mitigating these challenges will ensure that the process development and manufacturing timelines and deliverables will be maintained.

In this webinar industry experts will provide insights on how biotech organizations and their CDMO partners can effectively plan and execute a successful drug development program, from pre-clinical to IND.

Two case studies will be presented that illustrate how analytical and process development activities are performed to meet timelines and process needs.

Speakers:
Speaker
Abigail Guce-Merriam
Merck
Manager, Downstream Process Development
Speaker
Joshua Arias
Merck
Technical Lead, CDMO Services

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Rapid Replication Competent Adenovirus (rRCA) Detection: Accelerate your Lot Release

Subcategory: Biopharm Services and Solutions
Duration: 45 minutes
Date: 28 April, 2022

In this webinar, you will learn about:
  • Regulatory framework for adenoviral vector products
  • Considerations for lot release testing of adenoviral-based therapies
  • Advantages of a rapid method for RCA testing on production lot material
Detailed description:
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.

Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.

Speakers:
Speaker
Axel Fun, Ph.D.
Merck
Principal Scientist
Speaker
Alberto Santana, MBA
Merck
Product Manager, Biologics Biosafety Testing

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Top Reasons to Outsource your Early Biologic Development and Manufacturing to a CDMO

Subcategory: Biopharm Services and Solutions
Duration: 45 minutes
Date: 10 February, 2022

In this webinar, you will learn about:
  • Top reasons to outsource to a CDMO
  • Overcoming hurdles with a CDMO partnership
  • What early-stage biotechs should look for in a CDMO
Detailed description:
A recent survey commissioned by our company across more than 50 small, mid-sized and large biopharmaceutical companies worldwide, shed light on the key reasons why biotechs outsource their early biologic development and manufacturing to a CDMO.

In this 20-minute panel discussion, members of our End-to-End Solutions team, part of the BioReliance® portfolio, will offer their perspectives on what we heard from respondents. We will discuss major hurdles biotechs mentioned and how a customer-centric CDMO partnership can help overcome these, dismissing the idea of one-size-fits-all.

Speakers:
Speaker
Magali Toueille, Ph.D.
Merck
Downstream Process Development Manager
Speaker
Celine Raymond, Ph.D.
Merck
Upstream Process Development Manager

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ChetoSensar™ Technology Platform: Consider it DisSolved

Subcategory: Biopharm Services and Solutions
Duration: 30 minutes
Date: 16 November, 2021

Detailed description:
The optimization of solubility is an integral cornerstone in ADC development. En route towards novel ADCs, the optimization of solubility of drug candidates is still a challenge to tackle as the linker payloads alter the characteristics of the biologic. Poor solubility impacts not only manufacturability but as well DMPK properties and therefore the therapeutic window.

The novel ChetoSensar™ technology platform, a chemical modifiable carbohydrate motif, addresses this topic. The attachment of ChetoSensar™- tagged linkers to biomolecules increases the hydrophilicity and therefore decreases aggregation. The ChetoSensar™ oligosaccharide can be used flexibly and works with a variety of linker and payload combinations. The obtained ADCs showed a favorable efficacy in vivo and thus expanded our reach to challenging ADC constructs.

In this lecture, we introduce this technology and highlight its use within the ADC field.

Speakers:
Speaker
Carl Deutsch, Ph.D.
Merck
Director for ADC Chemistry and Cell Biology
 
 
 
 

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Advantages of Developing Processes and Manufacturing API with Single-Use Technologies

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 28 October, 2021

In this webinar, you will learn about:
  • Designing a GMP biologic commercial manufacturing facility– a CDMO’s perspective
  • Single-use technology and its impact on the facility’s flexibility and capabilities
  • Customers’ advantages using single-use equipment for process development, clinical and commercial production
Detailed description:
When biopharma companies move towards commercial manufacturing their focus shifts towards demand forecast, capacity constraints, and lifecycle management. Whether you chose a CDMO partner as a second-source manufacturer or to fully outsource your commercial manufacturing, quality, flexibility and cost-effectiveness are top priorities.

In this webinar, our experts will shed light on how we are currently designing our new biologic GMP commercial manufacturing facility in France that will go live in one year from now.

Flexibility is at the heart of our facility planning and set-up. We will showcase the advantages of single-use technology and its impact on the plant’s running costs, flexibility and capabilities e.g. for perfusion.

In 2012, we converted our GMP clinical manufacturing facility into 100% single-use technology. Today, our process development capabilities and our GMP clinical drug substance supply are based on single-use technology. Being a CDMO and a product provider, we are leveraging our industry leading single-use technologies to help our customers minimize risk and optimize speed for scale up and tech transfer. Using and sharing our first-hand experience combined with modern facility conceptual design, we will walk you through our facility planning, the ballroom concept and showcase what we mean by flexibility.

Speakers:
Speaker
Laetitia Botrel
Merck
Head of Business Planning and Operation
Speaker
Jérôme Pionchon
Merck
Global Facility Engineering Expert

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Releasing Your AAV Therapy with Confidence: Regulatory Considerations and Key Assays

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 29 July, 2021

In this webinar, you will learn:
  • Critical biosafety considerations for AAV vectors based on the latest regulatory guidance
  • How replication competent AAV testing fits into your bulk and final release testing package
  • The benefits of routine and platform assays over custom assay development
Detailed description:
Adeno-associated virus (AAV) vectors possess a number of advantages for use in human therapy including: high titer preparations, low immunogenicity, capacity to infect a wide range of cell types, and replication deficiency. Even with these advantages, there are biosafety concerns to consider when using AAV vectors.

This webinar will discuss key regulatory considerations across the manufacturing process, from the helper/packaging plasmids through to lot release testing. We will highlight critical assays that are required and delve into specifics on replication competent AAV testing and infectious titer determination by TCID50.

Speakers:
Speaker
Steven McDade
Merck
Senior Technical Specialist, Field Technology Management
Speaker
Alfonso Lavorgna, Ph.D.
Merck
Operations Manager, Virology Services

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Getting it Right. A Candid Conversation About Remote Viral Clearance Studies

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 1 July, 2021

In this webinar, you will:
  • Learn how Provise™ Viral Clearance services eliminate the need for travel
  • Understand considerations to prepare for a successful study in advance
  • Hear directly from a technical specialist who understands viral clearance study challenges and a project manager who has guided hundreds of biopharma manufacturers
Detailed description:
Join us as our head of project management discusses preparing for a viral clearance study from the client perspective with a technical specialist. Discover how we partner with you early on study design and discuss study preparation considerations, potential challenges, and how we deliver best-in-class Provise™ clearance services without the need to ever travel.

Speakers:
Speaker
Kristen Heslin, BS, MBA, PMP®
Merck
Head of Business Planning and Implementation
Speaker
Joshua Huffer
Merck
Technical Specialist, Viral Clearance Services

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Optimize Your Process Validation Package

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 24 June, 2021

In this webinar, you will discover more about:
  • How outsourcing to a CDMO partner in late-stage will increase flexibility and speed
  • How a risk-based approach can help you optimize your process validation strategy
  • How we have implemented a risk-based approach for our clients
Detailed description:
As you advance your biologic drug towards commercial manufacturing and Marketing Authorisation Application (MAA), you need to start process validation activities, and in many cases, you have limited information and data available from the clinical stage. Quality By Design (QBD) has become the gold standard to ensure quality risk management throughout the product life cycle. Statistical Design of Experiment is the method of choice to achieve this goal but finding the right balance between a large number of experiments and speed without sacrificing quality is not always easy. Actually, there are opportunities for more flexible approaches that focus on the critical process parameters and an appropriate process validation strategy.

In this webinar, we will focus on an adaptive, risk-based approach for an optimized process validation package that help biopharma companies accelerate their time to market.

The main objective is to demonstrate that the manufacturing process is capable of consistently producing acceptable quality products within the commercial manufacturing conditions. Outsourcing to an experienced CDMO with deep process understanding and robust quality systems in place can give you more options for flexibility and speed, while maintaining quality and patient safety.

Our validation experts will walk you through the steps of a risk-based approach, the residual risk and how we have optimized the validation strategy for clients.

Speakers:
Speaker
Christian Cattaruzza
Merck
Director of International Marketing
Speaker
Corinne Lavie-Cambot
Merck
Head of Innovation and Industrialization Department
Speaker
David Delvaille
Merck
Head of Process Validation
 
 
 
 

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Smart Bioprocess Data Management for Statistical Process Control and Advanced Analytics

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 15 June, 2021

In this webinar, you will learn:
  • Approach for end-to-end data management around QbD to CPV
  • Benefit from real-time monitoring for quality/process attribute and advanced control
  • Advanced statistical analytics – process/raw material identification and outlier detection
Detailed description:
End-to-end knowledge management is required during the life cycle of biopharmaceutical processes from development to manufacturing (QbD, PAT, CPV). In Bioprocessing 4.0, the wide range of data is important for scientific understanding, and speeding up data acquisition to analysis and control is essential, the real-time monitoring and smart data management are expected to push boundaries and unlocking unprecedented possibilities to transform drug manufacturing.

In this presentation, we would highlight the current challenges of bioprocessing data utilization and introduce the solution, and demonstrates the benefits of Bio4C™ ProcessPad and real-time monitoring of ProCellics™ Raman analyzer.

Speakers:
Speaker
Takao Ito
Merck
Principal Consultant, Asia Pacific Global BioPharm CoE
Speaker
Hemant Garg
Merck
Bio4C™ ProcessPad Product Manager

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Unveiling the Potential of your AAV Gene Therapy: Orthogonal methods to understand and define CQAs

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 8 June, 2021

In this webinar, you will learn:
  • How to identify and monitor the critical quality attributes (CQAs) of your AAV therapy
  • What assays to utilize to confirm capsid protein identity and quantity
  • Why you need to look to product characterization to identify and control important product-related impurities
Detailed description:
The potential of gene therapies to cure previously untreatable diseases has spurred the development of novel drugs, including those based on Adeno-Associated Virus (AAV). As with all biopharmaceuticals, it is important to identify and monitor the critical quality attributes (CQAs) of these products to ensure their safety and efficacy.

In this webinar, we will present a range of orthogonal methods to understand and define the CQAs of AAV products. These include assays for the confirmation of capsid protein identity and quantity, as well as the characterization of important product-related impurities, such as aggregates. Together these methods represent a comprehensive analytical testing package to support the characterization and lot release of AAV products.

Speakers:
Speaker
Martin De Cecco, Ph.D.
Merck
Development Services Manager, Product Characterization
Speaker
Piotr Kaczmarek, Ph.D.
Merck
Principal Scientist

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Setting up for Successful Lot Release Testing

Subcategory: Biopharm Services and Solutions
Duration: 1 hour
Date: 18 May, 2021

In this webinar, you will learn:
  • CMC testing requirements with CHO production platform for global commercialization
  • Lot release testing of product intermediates and final product
  • Product-specific qualification study
  • Alternative rapid testing methods to advance lot release testing
Detailed description:
CHO cells continue to serve as a key cell substrate for the manufacturing of recombinant proteins that span beyond therapeutic monoclonal antibodies and including subunit vaccines.

In this presentation, we will cover the CMC testing requirements with CHO production platform for global commercialization, Lot release testing of product intermediates and final product, product-specific qualification study and highlight the application of new testing methods and the benefits they bring to advance Lot Release Testing.

Speakers:
Speaker
Edmund Ang
Merck
Senior Technical Specialist
 
 
 
 

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Subcategory: Cell Culture

Developing Robust Media Formulations for Optimal Productivity and Product Quality

Subcategory: Cell Culture
Duration: 1 hour
Date: 1 October, 2024

In this webinar, you will learn:
  • The winning combination - why diverse libraries and raw materials characterization are so important
  • Next-generation media development through data mining of critical biochemical components
  • Case studies: CHO Fed-batch development and Perfusion considerations
  • Global manufacturing supply network, and the role of cell culture media services in every step of the molecule journey
Detailed description:
Maximizing productivity and quality in your upstream biologic manufacturing. Join us for an exclusive webinar on developing robust cell culture media formulations. Explore the critical role of leveraging diverse libraries and raw material characterization and gain valuable insights into data-driven development for optimal productivity and quality. From statistical design approaches to advanced explorations, this webinar will equip you with the knowledge to enhance your cell culture media development strategies. Don't miss this opportunity to stay at the forefront of bioprocessing innovation!

Speakers:
Speaker
Jochen Sieck
Merck
R&D Director
Speaker
Rain Lee
Merck
Regional Strategy Execution Manager, Upstream APeC

How to Boost AAV Titer with Feed Supplementation in both HEK293 and Sf-9 Platforms

Subcategory: Cell Culture
Duration: 1 hour
Date: 18 June, 2024

In this webinar, you will learn:
  • How to boost AAV titers in HEK293 and Sf-9 cell lines
  • Insider tips on volume and timing optimization
Detailed description:
To respond rapidly to urgent customers inquiries for recommendations to increase AAV titers in established AAV production processes, we evaluated a selection of our company's media and feed products as supplements during AAV production. We found Cellvento® ModiFeed Prime significantly increased AAV titers in HEK293 cell lines when supplemented post-transfection and in Sf-9 cell lines when supplemented post-infection. The volume and timing of the supplementation are critical for maximizing AAV titers and will be reviewed during this webinar.

Speaker:
Speaker
Jessica J Haywood
Merck
R&D Scientist
 
 
 
 

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AAV Upstream Process Development: A collaboration with Synplogen Japan

Subcategory: Cell Culture
Duration: 1 hour
Date: 6 June, 2023

In this webinar, you will hear from the Synplogen team about their:
  • Journey from R&D to scale-up
  • Experience in developing a robust and scalable upstream platform
  • Future plans to enable AAV gene therapies
Detailed description:
Gene therapies have revolutionized the way we can treat diseases of previously unmet need. However patient urgency and high costs mean that more efficient methods of production are sorely needed.

AAV vectors are forecasted to be the dominant form of gene therapies because they have superior safety profiles. Therefore, solutions for rapid and scalable production will be key to bring these therapies to patients.

Our partner Synplogen will share their experience in developing a robust and scalable upstream AAV platform for gene therapies.

Speakers:
Speaker
Shunsuke Saito
Synplogen
Director, Medical Business Unit
Speaker
Kentaro Hayashi, Ph.D.
Synplogen
Head, DNA Synthesis Business Unit
Speaker
Yoshinori Takagi, Ph.D.
Synplogen
Officer, Medical Business Unit R&D
Speaker
Ning Li
Merck
Technology Application Expert for Upstream APeC, Customer Application

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CellPrime® rLR3 IGF-1 Optimizing Cell Culture Productivity

Subcategory: Cell Culture
Duration: 38 minutes
Date: 16 March, 2023

In this webinar, you will learn:
  • CellPrime® LR3 physiological response in cells
  • How CellPrime® LR3 can enhance cell proliferation, viability and production
  • How to optimize media formulations using CellPrime® LR3
Detailed description:
CellPrime® rLR3 IGF is used to optimize cell culture formulations to increase cell proliferation, productivity, and viability. With an exact match for the Type I IGF receptor and a lower affinity for IGF binding proteins, CellPrime® rLR3 IGF has increased effectiveness in serum-free cell culture media.

We will focus on how CellPrime® rLR3 behaves in cell culture media and provide details on how supplementing media with Cellprime® rLR3 IGF-I alone, or in combination with insulin, can speed growth as well as increase viable cell density and protein production.

Speaker:
Speaker
Dennis Binder
Merck
Head of QC Cell Culture Media
 
 
 
 

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Flexible, Simplified, and Scalable Solutions for AAV Viral Vector Production

Subcategory: Cell Culture
Duration: 1 hour
Date: 22 October, 2022

In this webinar, you will learn:
  • Market insights, overall process considerations & trends for AAV
  • High-performing suspension-based AAV upstream production platforms: VirusExpress® and Sf-RVN®
  • Simplify and optimize your HEK-based suspension cell culture processes with the new Cellvento® 4HEK
Detailed description:
The adeno-associated virus (AAV) is the leading viral vector for in vivoin vivo gene therapy. Currently, production is labor intensive and expensive because of adherent cell culture processes. The use of stirred-tank bioreactors allows scalable and robust processes to be developed to meet the most demanding needs for high-dose indications that target large organs, e.g. muscle, skin or blood. High-performing cell culture media is also crucial to ensure consistent supply.

Here, we highlight the development of two suspension-based AAV upstream production platforms, and describe simplified cell culture processes to enable efficient and cost-effective solution for large scale AAV production.

Speaker:
Speaker
David Loong, Ph.D.
Merck
Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Speaker
Rain Lee
Merck
Upstream Technical Application Expert, SEATW & Oceania

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Cold hard facts: Implementing high cell density cryopreservation in your intensified seed train

Subcategory: Cell Culture
Duration: 1 hour
Date: 15 September, 2022

In this webinar, you will:
  • Receive an overview of intensified upstream processing
  • Learn how the HCDC process employs a closed single-use system, significantly reducing contamination risk and improving reproducibility
  • Understand how using a perfused N-1 step can either decrease your facility footprint or increase your biomass generation in your seed train
Detailed description:
This presentation explores the use of a high cell density cryopreservation (HCDC) method that utilizes bag assemblies specifically designed for freezing cells at higher densities and larger volumes, enabling to directly inoculate the N-2 bioreactor.

The integration of a perfused N-1 step in upstream process is highlighted to either decrease facility footprint or to be able to inoculate final fed-batch N-stage with a higher cell density as a conventional fed-batch. This streamlined method of initiating cell expansion can reduce the number of intermediate cell culture unit operations, allowing to shorten expansion process by 10 days and to decrease the runtime of final N-stage bioreactor.

Speaker:
Speaker
Chris Kornfeld
Merck
Technical Consultant, Upstream Manufacturing Sciences and Technology
 
 
 
 

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Get the Most out of Your Fed-batch Process with Cellvento® ModiFeed Prime COMP

Subcategory: Cell Culture
Duration: 39 minutes
Date: 27 September, 2022

In this webinar, you will learn:
  • Highly concentrated formulation minimized total feed volume (15-27.5%) resulting in maximized bioreactor working volume, decreased product dilution, and increased yield
  • Compacted single-part feed simplifies hydration, storage, and feeding
  • Auto pH to near neutral eliminates use of acids or bases in hydration and the influence of high or low pH feeds on the fed-batch process
  • The option to store hydrated feed protected from light at either 2-8 °C for up to 90 days or room temperature for up to 30 days provides streamlined workflows and reduced contamination risk
Detailed description:
Introducing Cellvento® ModiFeed Prime COMP, a new easy to hydrate, single-part pH neutral feed. This highly concentrated, compacted feed reduces the volume to be added to bioreactor while increasing product yield. The feed is also stable at room temperature when protected from light, allowing it to remain connected to the bioreactor for easy multiple feedings, thereby streamlining workflows and reducing contamination risk.

The feed supports optimal cell growth and high productivity for wide range of industrial suspension CHO cell lines. When used in combination with Cellvento® and EX-CELL® Advanced media, it boosts productivity beyond our existing feeds and competitive feeds tested.

Speaker:
Speaker
Rain Lee
Merck
Upstream Technical Application Expert, SEATW & Oceania
 
 
 
 

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Quality Improvement in Implemented Cell Line Development Process Based on the CHOZN-GS System

Subcategory: Cell Culture
Duration: 1 hour
Date: 31 May, 2022

In this webinar, you will learn:
  • Quality-driven screening procedures on various Fc-fusion protein
  • Enhanced target clone selection methods
Detailed description:
Upstream process development is a critical step in ensuring that the needed protein quality is met on a large-scale. However, due to the inherent properties of the selected clone, the Research Production Cell Banks, which is derived mainly based on initial high productivity, frequently delays the subsequent process development. In the cell line development stage, we recently used the CHOZN-GS system to apply our quality-driven Fc-fusion protein screening procedures to select appropriate clones that ranged in the target product quality. Our strategies can also be used as an enhanced cell line development platform with high titer and developability.

Speaker:
Speaker
Dr. Young Min Oh
GI Innovation
Managing Director
 
 
 
 

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Addressing Downstream Challenges with Complex Injectables

Subcategory: Cell Culture
Duration: 1 hour
Date: 29 March, 2022

In this webinar, you will learn:
  • Why downstream processing (specifically sterile filtration) is critical and complicated
  • Sterile filtration of liposomes, nanoparticles and viscous formulations
  • Filter validation aspects and where our approach is different
Detailed description:
The complex injectable market is gaining traction in the injectable therapies, however manufacturing of it is critical. In this webinar, lets brainstorm on the downstream criticalities of these molecules and how to handle the same.

Speaker:
Speaker
Partha Banerjee
Merck
Senior Technology Consultant
 
 
 
 

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Risk Mitigation in Cell Line Development: Regulatory Considerations and Impact on Quality Assurance

Subcategory: Cell Culture
Duration: 1 hour
Date: 7 December, 2021

In this webinar, you will learn about:
  • Risk assessment approaches in upstream process development
  • How early cell line development stage is linked to subsequent steps in the bioprocess to assure the quality of the final product
  • Benefits of having a completely chemically defined cell line development process
Detailed description:
Chinese Hamster Ovary (CHO) cells are the preferred host for producing biotherapeutics where cell line development (CLD) is the foundation of the bioprocess. CLD processes are expected to be robust while meeting a myriad of regulatory requirements. The choice of production cell line, culture conditions, and having a chemically defined (CD) CLD process by using CD cloning media can impact the subsequent measures for the CMC (Chemistry, manufacturing, and controls).

In this presentation, we will discuss these choices and their impacts on subsequent bioprocess and CMC testing required by regulations and the benefits of incorporating CD cloning media into the CHOZN® expression platform.

Speakers:
Speaker
Janice Tan, Ph.D.
Merck
Head of Upstream MSAT, Asia Pacific excluding China
Speaker
Edmund Ang, Ph.D.
Merck
Senior Technical Specialist

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Subcategory: Chemicals and Raw Materials

Business Continuity Management: Principles and Lessons Learned from the Benzonase® Success Story

Subcategory: Chemicals and Raw Materials
Duration: 1 hour
Date: 18 April, 2024

In this webinar, you will learn:
  • Key principles of Business Continuity Management
  • Best practices for a robust supply chain
  • How it translates into success stories, like with the Benzonase® family
Detailed description:
Business Continuity Management is a key success contributor to the pharma industry. As industry leader, we will share our BCP principles for a safe and robust supply chain. Analysis from the Benzonase® Business Continuity Plan and Safety-Stock Build-Up Strategy 2019-2023 will also be discussed as an example. Indeed, during Covid-19, more than 2 Billion of vaccines doses were manifactured using this product family. This would not have been possible without a multi year planning strategy.

We'll describe why this product has one of the strongest supply chain in the industry.

Speakers:
Speaker
Andrew Goldman
Merck
Head of Business Continuity Management
Speaker
Sarah Lechat
Merck
Global Marketing Manager - Enzymes and DSP Chemicals

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AAV Process Intensification Using High Salt Lysis & Benzonase® Salt Tolerant Endonuclease

Subcategory: Chemicals and Raw Materials
Duration: 1 hour
Date: 26 October, 2023

In this webinar, you will learn about:
  • Our portfolio of cGMP Benzonase® endonucleases
  • Our new Benzonase® Salt Tolerant endonuclease Emprove® Expert
  • DNA & chromatin removal at high salt lysis concentrations for AAV processes
  • Benzonase® endonucleases efficiency under different detergent conditions for AAV processes
  • Operating conditions for Benzonase® Salt Tolerant endonuclease
Detailed description:
Attention all Cell & Gene Therapy Experts! A New Benzonase® is Born.

Do you find challenging to remove HcDNA and chromatin stuck with AAV capsids after cell lysis? To overcome one of the main challenges of the gene therapy industry, we engineered our new Benzonase® Salt Tolerant Endonuclease Emprove® Expert. This new Benzonase® was developed to remove residual host cell and plasmid DNA under high salt lysis conditions where classical endonuclease enzymes are inactive.

In this webinar we will demonstrate the enzyme efficiency and showcase its compatibility with detergents used for HEK293 and Sf9 cell lysis, like our Deviron® portfolio.

Join us to move your AAV process to the next level.

Speakers:
Speaker
Dmitry Zabezhinsky
Merck
Head of Business Continuity Management
Speaker
Sarah Lechat
Merck
Global Marketing Manager - Enzymes and DSP Chemicals

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Managing Nitrite Impurities: A Combined Supplier-Manufacturer View to Nitrosamine Risks

Subcategory: Chemicals and Raw Materials
Duration: 1 hour, 14 minutes
Date: 28 September, 2023

In this webinar, you will learn:
  • Impact of the presence of nitrites in excipients on the risk for nitrosamine formation
  • The landscape of small and drug substance related nitrosamines in pharmaceuticals
  • Identifying nitrosatable structures in APIs and related impurities, assessing their potential to form nitrosamines
  • Case study on mitigation of NDMA formation in Metformine products
  • Approach for testing nitrite levels in pharmaceutical excipients
  • Example for a strategy to mitigate risk of nitrosamine formation.
Detailed description:
The presence of nitrites in excipients evolved as a hot topic among regulatory agencies across the world. This Nitrites in excipients are seen as a risk factor to form nitrosamines in the presence of vulnerable amines during drug product manufacturing process and storage. Health Authorities worldwide imposed recalls to drug products. Our data indicate that the presence of nitrosamines in pharmaceuticals is likely more prevalent than originally expected. This webinar will review the current regulatory considerations, the role of nitrites, the analytical controls. The view of a drug product manufaturer on the related risk mitigation strategy and a case study on risk mitigation is presented.

Speakers:
Speaker
Ulrich Reichert, Ph.D.
Merck
Head of CDMO and Bioprocess Materials
Speaker
Joerg Schlingemann, Ph.D.
Merck
Director, Global Quality Control Principal Expert
Speaker
Sebastian Hickert
Merck
Senior Manager for Analytical and Preparative Liquid Chromatography
 
 
 
 

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Deviron® C-16, a Sustainable Replacement to Triton™ X-100

Subcategory: Chemicals and Raw Materials
Duration: 47 minutes
Date: 9 August, 2023

In this webinar, you will learn:
  • Major concerns with the use of Triton™ X-100
  • Deviron® C16 is sustainable replacement to Triton™ X-100
  • Virus inactivation in Monoclonal antibodies and plasma industries using Deviron® C-16
Detailed description:
Virus inactivation is critical in purification of Biotherapeutics. Triton™ X-100 is most used detergent for virus inactivation in monoclonal antibodies, plasma industry and for bacterial cell lysis. However, Triton™ X-100 has been categorized as hazardous chemical due to its strong endocrine effects after it biodegrades and has got attention to be prohibited for manufacturing by European regulation (REACH). Considering REACH recommendations and health concerns, Merck has limited production of Triton™ X-100 with authorization from REACH and would discontinue over a period. To provide an alternative and help existing users of Triton™ X-100, Merck has developed DEVIRON® C16, a sustainable product to replace Triton™ X-100. DEVIRON® C16 has shown great performance and is as effective as Triton™ X-100 in the inactivation of viruses.

Speakers:
Speaker
Sateesh Poojari
Merck
Field marketing specialist India & neighboring countries - Biopharma materials
 
 
 
 

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Managing Endotoxins - Detect, Prevent, Remove

Subcategory: Chemicals and Raw Materials
Duration: 1 hour, 17 minutes
Date: 20 July, 2023

In this webinar, you will learn:
  • Possible endotoxins contamination sources during manufacturing
  • Ecologically sustainable methods of detecting endotoxins that do not involve animals
  • Considerations for selecting raw materials for production
  • Strategies for endotoxin removal
Detailed description:
Endotoxins are heat-stable lipopolysaccharide (LPS) and a component of the exterior cell wall of gram-negative bacteria. Bacteria shed endotoxin in large amounts upon cell death and when they are actively growing and dividing. Since endotoxins are pyrogenic in mammals, to ensure the safety of a patient, endotoxin content in the drug should always be controlled.

Speakers:
Speaker
Markus Greulich
Merck
Strategic Marketing Manager, Excipients Liquid Application
Speaker
Subhasis Banerjee
Merck
Principal Bioprocessing Application Expert, APAC Bioprocessing
Speaker
Prateek Garg
Merck
Segment Marketing Manager, Therapeutic Proteins & Small Molecules
Speaker
Brittany Gall
Merck
Strategic Marketing Manager, Upstream Chemicals

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Material Attributes of Poloxamer 188 Affecting the Application in Cell Culture and Liquid Protein Formulation

Subcategory: Chemicals and Raw Materials
Duration: 1 hour
Date: 6 June, 2023

In this webinar, you will learn:
  • the function of Poloxamer 188 as stabilizer in biopharmaceutical products
  • the function of Poloxamer 188 as shear stress protector in cell culture
  • the impact of material attributes on the different applications of Poloxamer 188 in liquid protein formulation and in cell culture media
Detailed description:
Poloxamer 188 finds wide application in the development and manufacturing process of pharmaceutical drug products. In liquid protein formulations, Poloxamer 188 (PLX188) is added to stabilize proteins against mechanical stress, ensuring the desired therapeutic activity and safety of biologics. In cell culture media, PLX188 is added as shear stress protector to prevent cell damage during the cultivation in bioreactor and guarantee optimal cell growth.

We will show how the performance of PLX188 in these applications can be affected by variations in molecular weight or hydrophobicity, observed among different batches or products.

Speakers:
Speaker
Nelli Erwin
Merck
Strategic Marketing Manager - Emerging Modalities and Innovation BPM
Speaker
Alice Antonello
Merck
Senior Scientist - Bioprocess Chemistry

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CHO Fed Batch Process Simplification using Cellprime Growth Factors and Innovative Chemicals

Subcategory: Chemicals and Raw Materials
Duration: 41 minutes
Date: 2 May, 2023

In this webinar, you will learn:
  • CHO cell culture media components
  • Non-animal origin growth factors
  • Usage of Modified amino acids for fed batch simplification
Detailed description:
CHO cell culture media provides all the nutrients like amino acids, buffers, growth fatcors, vitamins and lipids which are required for cellular growth and metabolism. Growth factors like insulin and insulin analogues are critical for cell growth, proliferation and to achieve higher productivity.

CHO cell culture media provides all the nutrients like amino acids, buffers, growth fatcors, vitamins and lipids which are required for cellular growth and metabolism. Growth factors like insulin and insulin analogues are critical for cell growth, proliferation and to achieve higher productivity.

Speakers:
Speaker
Sateesh Poojari
Merck
Sr. Technical Application Expert
 
 
 
 

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The use of Meglumine within the Developability Classification System and Beyond

Subcategory: Chemicals and Raw Materials
Duration: 1 hour
Date: 7 March, 2023

In this webinar, you will learn:
  • How the developability classification system emerged from the well-established biopharmaceutics classification system
  • How the DCS can distinguish between solubility and dissolution rate limited compounds
  • How Meglumine can help with improving solubility
  • Which other formulation challenges Meglumine can solve
Detailed description:
The Developability Classification System (DCS) is a modification of the well-established Biopharmaceutics Classification System (BCS) that focuses on the underlying reasons of poorly soluble compounds: Dissolution rate limitations (DCS IIa) and solubility limitations (DCS IIb).

By using the DCS we will focus on how Meglumine, an amino sugar, can support in solving challenges with poorly soluble compounds as well as API stability and how it can be used in advanced manufacturing technologies such as hot melt extrusion (HME).

Speakers:
Speaker
Erik Peiter
Merck
Strategic Marketing Manager: Excipients Solid Application

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How to Improve API Solubility by Salt and Cocrystal Formation

Subcategory: Chemicals and Raw Materials
Duration: 1 hour
Date: 22 November, 2022

In this webinar, you will learn:
  • How salt and cocrystal formation can improve your API's solubility
  • What are the respective benefits for your API
  • How to identify and select suitable coformers for your API
  • Which regulatory implications are involved
Detailed description:
Development of new active pharmaceutical ingredients (APIs) is lengthy and cost-intensive, thus avoiding any potential risk that may limit the product's success is of utmost importance. Today, many APIs are not being commercialized as they are poorly water soluble (BCS class II and IV) and, as a result, exhibit too low bioavailability.

Diverse API processing techniques have evolved to be chosen from to improve drug solubility, but also stability and processability. Learn in which cases salt or cocrystal formation are your techniques of choice, how to find the right coformers for your API, and how to avoid the obstacles: so that you can care about commercialization, not solubilization.

Speakers:
Speaker
David Luedeker, Ph.D.
Merck
Principal Scientist - Solid Formulation
 
 
 
 

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Arcofolin® - Why the Form of Folate Matters

Subcategory: Chemicals and Raw Materials
Duration: 1 hour
Date: 11 November, 2022

In this webinar, you will learn about:
  • The contribution of sufficient folate supply to body functions and health
  • Established and emerging target groups for uptake of methylfolate
  • The need for an alternative for folic acid
  • Why methylfolate is the next generation folate of choice
Detailed description:
Folate is an essential B-vitamin and, as such, indispensable for many dietary supplements. Low levels of folates are associated with a number of disorders, such as anemia, neural tube defects, and depression. Fortification of foods with synthetic folic acid eliminated severe folate deficiency, but folate insufficiency is still widespread and has also been linked to aging-associated diseases. Synthetic folic acid can also lead to unmetabolized folic acid in blood and as such has been associated e.g. with cancer.

In contrast, Arcofolin®, unlike synthetic folic acid, is nature-alike and a directly bioavailable source of folate. This next generation folate has a faster absorption, does not need to be metabolized by the liver, and is more efficient in boosting plasma active folate levels than folic acid.

Speakers:
Speaker
Rima Obeid, Ph.D.
Saarland University Hospital
Professor, Department of Clinical Chemistry and Laboratory Medicine, Central Laboratory
Speaker
Jean-Pierre Knapp
Merck
Senior Scientist, Analytics Quality Services

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How to Select Optimum Preservative for Liquid Formulation

Subcategory: Chemicals and Raw Materials
Duration: 1 hourm 15 minutes
Date: 25 October, 2022

In this webinar, you will learn:
  • The selection basis for preservative in pharmaceuticals
  • Critical aspects to be considered while screening different preservatives
  • pH and preservatives activity co-relation
  • Optimization of preservative action through synergistic action
Detailed description:
Preservatives are unique set of excipients which have critical role to protect degradation of formulation from microbial contamination and prolong shelf life of formulation. Ideal preservative should be non-toxic, inert, compatible, wide-microbial activity etc. Selection of preservatives is very critical task because it depends upon multiple factors like route of administrations, pH of formulation, type of formulation, toxicity, compatibility with other excipients etc.

Speakers:
Speaker
Smita Rajput, Ph.D.
Merck
Field Marketing Manager-India, SEA & Oceania
Speaker
Prateek Garg
Merck
Global Segment Marketing Manager, Small Molecules

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How to Accelerate and Enhance ADC Therapies

Subcategory: Chemicals and Raw Materials
Duration: 1 hour
Date: 21 April, 2022

In this webinar, you will learn about:
  • The advantages of using advanced intermediates to develop ADC therapies
  • How to increase ADC solubility and efficiency
  • Fast, small-scale ADC library generation
  • Seamless supply chain with reduced complexity and regulatory support
Detailed description:
The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window.

Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.

Speakers:
Speaker
Ross Bemowski, Ph.D.
Merck
Associate Director of Analytical Development
Speaker
Jeffery Carroll
Merck
Senior Scientist, Team Lead ADC Express, Process and Analytical Development

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2021 Virtual PEG Symposium

Subcategory: Chemicals and Raw Materials
Duration: 2 hours
Date: 17 June, 2021

During this symposium, you will:
  • Learn about next generation of protein PEGylation and PEG analytics
  • Get perspectives on regulatory aspects for activated PEGs in pharmaceutical applications
  • Discuss and tackle today’s PEG challenges with your peers
Detailed description:
This technical symposium is a unique opportunity to discover enabling technologies and today's trends in the broad field of pharmaceutical PEG applications, development, and processing.

Industry experts will present the latest progress in activated PEGs and conjugation chaired by Lisa McDermott from the Life Science business of Merck KGaA, Darmstadt, Germany.

Speakers:
Speaker
Lars Albermann, Ph.D.
Merck
Head of Pharma Registration and Regulatory Projects
Speaker
Lisa McDermott
Merck
Director, Process and Analytical Development
Speaker
Tobias Haag, Ph.D.
Merck
Head Process and Analytical Development, Schaffhausen
Speaker
Marco Passafaro, Ph.D.
Merck
Senior Scientist, R&D Drug Delivery Compounds

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Subcategory: Downstream

Holistic Approach to Optimize Viral Vector Harvest

Subcategory: Downstream
Duration: 1 hour
Date: 4 July, 2023

In this webinar, you will learn:
  • overview of the unique challenges related to AAV based gene therapy development
  • considerations & challenges for robust and efficient viral vector harvesting & purification
  • strategies and solutions for an efficient and robust harvesting & purification
Detailed description:
Viral vectors have been a game-changer in the biomedical industry. However, the feed streams for viral vector manufacturing has introduced major harvest challenges, due to the character of viral vectors and its manufacturing process.

This webinar addresses an overview on the aspects and the unique challenges around viral vector harvest, from detergent candidates and DNA digestion optimization, to key points in designing clarification and purification at the downstream process. By addressing such points, this webinar would give you some fresh insights on viral vector harvest step.

Speakers:
Speaker
Meghan Peng
Merck
Biopharm Materials Technical Application Expert
Speaker
Yuki Tsunakawa
Merck
Downstream Technical Application Expert

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Process Development and Intensification for Ultrafiltration/Diafiltration of Viral Vectors

Subcategory: Downstream
Duration: 1 hour
Date: 29 June, 2023

In this webinar, you will learn about:
  • Methods to develop, optimize and scale up a TFF process for viral vector manufacturing with different operating strategies
  • Intensifying the downstream purification process for viral vectors
  • Process performance characteristics of different single-use technologies available for viral vector manufacturing
Detailed description:
Fast and efficient processes with reliable scale-up capabilities are essential for viral vector manufacturing. The primary tangential flow filtration (TFF) step - through ultrafiltration and diafiltration (UF/DF) - can intensify the purification process prior to chromatography steps.

We will explore two operating strategies, transmembrane pressure (TMP) and permeate control, while considering their impact on process time, viral yield, and impurity removal. We then compare performance of commercially available single-use TFF modules for processing viral vectors. These insights offer a foundation for process development and optimization of processing viral vectors.

Speakers:
Speaker
Anand Alembath
Merck
Development Engineer
Speaker
Rosario Cervellere
Merck
Applications Engineer

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How will ICH Q5A(R2) Affect the Design of Virus Clearance Studies?

Subcategory: Downstream
Duration: 1 hour
Date: 28 February, 2023

In this webinar, you will learn:
  • The key updates in the ICH Q5A (R2) and how these may impact virus clearance study design
  • How modified spiking approaches can be used to address virus clearance requirements for continuous chromatography
  • Incorporating virus reduction specific steps into the manufacturing process for viral vectors
Detailed description:
Since its issue in 1999, ICH Q5A(R1) has been one of the key guidelines that shaped the design of virus clearance studies for recombinant protein products. ICH Q5A(R2), published September 2022, includes a number of updates that may impact the design of virus clearance studies in the future.

Key aspects driving these changes use new manufacturing technologies such as continuous processing and new modalities, including cell and gene therapy vectors. This webinar will discuss the updates and review aspects using alternative virus spiking approaches to address clearance for continuous chromatography and how to build virus reduction capacity into the manufacturing process of viral vectors.

Speakers:
Speaker
Steven McDade
Merck
Associate Director, Sales Development, APAC
Speaker
Sandra Hon
Merck
Demand Generation Marketing Manager, Asia Pacific

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How Updates to EU GMP Annex 1 Impact Sterilizing Filtration in Single Use Systems

Subcategory: Downstream
Duration: 1 hour
Date: 2 February, 2023

In this webinar, you will:
  • Receive a summary of key updates to EU GMP Annex 1
  • Learn how your filtration systems can help meet the requirements of Annex 1
  • Learn how comprehensive supplier testing information accelerates implementation of single use systems
Detailed description:
The recently published revision to Eudralex Vol. 4 Annex 1, clarified current expectations for manufacture of sterile medicinal products in light of improved process understanding and advances in processing technologies.

This webinar will summarize important elements of this revision and highlight how in single use filtration systems can contribute to a holistic contamination control strategy helping drug manufacturers meet regulatory expectations.

Speakers:
Speaker
Simone Biel, Ph.D.
Merck
Senior Regulatory Consultant
Speaker
Lauren Kacmarcik
Merck
Product Manager, Final Filtration
Speaker
Monica Cardona
Merck
Global Senior Program Manager, Single Use & Integrated Systems
 
 
 
 

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Vaccine Journey Bench to Market - Day 2

Subcategory: Downstream
Duration: 2 hours, 17 minutes
Date: 18 January, 2023

In this webinar series, you will learn:
  • Tech Transfer in Vaccine Manufacturing
  • Vaccine Development: from Schistosomiasis to COVID-19 vaccine
  • The after tech-transfer stories in the real world: bringing platforms to products
  • Trends and Costs in vaccine manufacturing
  • Applying Quality by Design Concept in Vaccine manufacturing
Detailed description:
Vaccine is entering a new era, and we would like to share some insights regarding to the market trends, projection, challenges, and potential solutions around future vaccine manufacturing topic. We would also discuss about the cost for vaccine manufacturing in both traditional and novel platforms.

Finally, we would like to share a topic on how Quality by Design is applied in vaccine manufacturing, the principles, the application with case studies with special feature in TFF technologies, and last but not least, the scale up consideration using the QbD concept.

Speakers:
Speaker
Ms. Josephine Cheng
Merck
Senior Consultant, Traditional Modalities APAC, BioP
Speaker
Subhasis Banerjee, Ph.D.
Merck
Principal Bioprocessing Application Expert
Speaker
Mr. Bin Wang
Merck
Director of Technical & Scientific Solutions Group, China
 
 
 
 

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Vaccine Journey Bench to Market - Day 1

Subcategory: Downstream
Duration: 2 hours, 23 minutes
Date: 17 January, 2023

In this webinar series, you will learn:
  • Tech Transfer in Vaccine Manufacturing
  • Vaccine Development: from Schistosomiasis to COVID-19 vaccine
  • The after tech-transfer stories in the real world: bringing platforms to products
  • Trends and Costs in vaccine manufacturing
  • Applying Quality by Design Concept in Vaccine manufacturing
Detailed description:
You will hear from all Key Opinion Leaders in the field, explaining a fascinating story behind the scene for COVID-Vaccine development, starting from key elements and considerations of Technology transfer in all aspects, to the long-term collaboration in a neglected tropical disease vaccine platform optimization, and how it later transformed into the COVID-vaccine candidates when the pandemic hit.

The more to come is the after-tech-transfer stories, how the research results evolved into global collaborations, and what challenges did the receiving parties encountered, how did they solve the challenges, and finally brought to market with real-world COVID-vaccine product, the first Indonesian Homegrown Halal-certified Covid-vaccine - Indovac.

Speakers:
Speaker
Ravi Ganapathy, Ph.D.
HLS (Hilleman Laboratories Singapore Pte Ltd)
Director, CMC R&D
Speaker
Prof. Maria Elena Bottazzi
Texas Children's Hospital Center for Vaccine Development, Baylor College of Medicine
Co-Director
Speaker
Ms. Dea Marsendah
Biofarma
Head of Development Management Department
 
 
 
 

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Collaboration to Develop Modular Facility Proof-of-Concept for Multi-Modal Bioprocessing Activities

Subcategory: Downstream
Duration: 1 hour
Date: 1 December, 2022

In this webinar, you will learn:
  • How to develop a proof-of-concept facility design that supports multi modal bioprocessing
  • Details about the specific design, timelines, and costs
  • How this modular facility approach can be leveraged for your specific requirements
Detailed description:
Gains in speed, flexibility, and agility are essential for drug and vaccine manufacturers. One innovative solution is the design and construction of manufacturing facilities using predesigned and prefabricated elements. These modular facilities respond to global demand for new medicines while overcoming the lack of predictability and flexibility that have historically burdened manufacturers.

This webinar describes the collaboration of our company and G-Con to develop a proof-of-concept facility design that enables multi-modal bioprocessing, including our process equipment, with greater flexibility and response time and facilitates tech transfer and future expansion. Details about the design, timelines, and costs will be included.

Speakers:
Speaker
Jérome Dalin
Merck
Senior Consultant - EMEA Traditional Modalities, Bioprocessing Strategy operationalization
Speaker
Thomas Hauser
G-CON Manufacturing
Business Development Manager EMEA

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Leveraging Traditional Chromatography Techniques for Downstream Purification of Novel Modalities

Subcategory: Downstream
Duration: 1 hour
Date: 14 April, 2022

In this webinar, you will learn:
  • Insights to AAV, LVV and pDNA process flows and manufacturing challenges
  • Compatibility of implementing IEX chromatography in downstream bioprocessing and alternatives to affinity chromatography
  • Data-driven case studies on the performance of Natrix®, Eshmuno® and Fractogel® family of resins in downstream purification
Detailed description:
Novel modalities such as adeno-associated virus (AAV), lentiviral vectors (LVV) and plasmid DNA (pDNA) are gaining prominence with clinical experience and commercialized treatments. A key barrier in bioprocessing of such complex molecules is in the downstream chromatography step where improving process recoveries and efficiencies remain top priorities. Could we leverage well-established, traditional chromatography steps using chemistries such as ion exchange (IEX) to de-bottleneck and streamline the purification of these newer therapies? Learn how to implement chromatographic techniques using resin or membrane formats in your viral vector or pDNA processes.

Speakers:
Speaker
Ratish Krishnan
Merck
Strategy Operationalization, Novel Modalities, Americas
 
 
 
 

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Effective and Efficient Design of a Downstream Purification Process for Plasmid DNA

Subcategory: Downstream
Duration: 1 hour
Date: 24 March, 2022

In this webinar, you will:
  • Get an overview of the pDNA market
  • Receive guidance for filter selection as a replacement for centrifugation
  • Learn purification strategies using AEX chromatography resins and membranes
  • Understand key considerations for sterile filtration
  • Learn about a complete purification process flow for pDNA
Detailed description:
Plasmid DNA (pDNA) is an important component of mRNA, vaccine, and viral vector therapies. Scaling and optimizing downstream processes during manufacturing requires an in-depth knowledge of all unit operations. This webinar presents a design for a generic manufacturing template which overcomes the challenges associated with the purification of pDNA i.e high viscosity, large molecule size, shear sensitivity, and similarities with impurities. Key considerations for purification unit operations include harvest, lysis, clarification, tangential flow filtration, chromatography to sterilizing grade filtration. The webinar presents a comprehensive case study encompassing all downstream unit operations.

Speakers:
Speaker
Nargisse El Hajjami, Ph.D. Eng.
Merck
Senior Consultant, Bioprocessing Strategy Operationalization
Speaker
Thomas Elich
Merck
Manager, MSAT Americas Purification Process Engineering
Speaker
Laurens Vergauwen
Merck
EMEA Process Development Scientist
 
 
 
 

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Viral Clearance - Something Went Wrong, What do I do Now?

Subcategory: Downstream
Duration: 45 minutes
Date: 3 March, 2022

In this webinar, you will learn:
  • About key risk areas in executing viral clearance studies
  • How to mitigate risks in designing viral clearance studies
  • What to do if you have insufficient clearance
  • How to deal with manufacturing deviations potentially affecting viral safety
Detailed description:
We will discuss potential issues that can arise during viral clearance study design and execution and strategies to mitigate certain risks. Even the strongest study design may encounter issues with sufficient clearance to reach the target safety expectations. Join us to learn how to troubleshoot these and manufacturing deviations that impact viral safety.

Speakers:
Speaker
Kathryn Martin Remington, Ph.D.
Merck
Technical Consultant
Speaker
Kate Smith
Merck
Principal Scientist

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Get Proactive With Your Stability Program

Subcategory: Downstream
Duration: 45 minutes
Date: 9 December, 2021

In this webinar, you will learn:
  • Key considerations on when and how to effectively plan your stability testing program
  • How to ensure the right selection of assays for your testing package
  • How forced degradation/accelerated studies may fit into your overall plan, and evaluating repeat stability requirements after CMC changes
Detailed description:
To ensure product safety and enhance understanding of product attributes, careful study of the effects of environmental conditions on your mAb is required throughout all phases of development.

Long and short-term stability studies are a critical part of a product development program and required by ICH guidelines. However, stability programs require extensive preparation and without this proper planning you may face additional hurdles.

Join our experts, Drs. Greg Pirozzi and Pamela Hamill, in a panel style discussion to learn how to proactively plan and execute a testing program to assess changes in stability that may impact product purity, potency and safety.

Speakers:
Speaker
Greg Pirozzi, Ph.D.
Merck
Senior Project Manager, Custom Projects
Speaker
Pamela Hamill, Ph.D.
Merck
Technical Consultant, Field Technology Management

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Payload Core Product Line Accelerates ADC Clinical Timelines

Subcategory: Downstream
Duration: 50 minutes
Date: 2 December, 2021

In this webinar, you will learn:
  • Advantages of dolastatin over other payloads in ADC therapies
  • Proprietary DOLCore™ and MayCore™ products
  • Flexibility to make new or established dolastatins
  • Rapid synthesis technology accelerating the path to drug commercialization
  • Seamless supply chain with reduced complexity and regulatory support
Detailed description:
Dolastatins are antimitotic peptides which exhibit highly potent cytotoxic effects in cancer cells. Due to their pronounced antitumor effects, dolastatins have demonstrated clinical success as payloads for ADCs. However, innovators still face numerous challenges when developing and manufacturing ADC therapies, leading to increased costs and delayed timelines. Our core product line aims to address these challenges.

DOLCore™ product is a versatile and advanced intermediate that can simplify the synthesis of dolastatin payloads by reducing the number of synthesis steps from 15-20 to four or fewer. The value of DOLCore™ translates to significant savings in development and manufacturing costs driven by risk reduction in payload synthesis and avoidance of supply chain disruption.

Speakers:
Speaker
David Goeddel, Ph.D.
Merck
Director of API R&D
 
 
 
 

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The Viscosity Reduction Platform: Enabling Subcutaneous (subQ) Delivery

Subcategory: Downstream
Duration: 1 hour
Date: 7 October, 2021

In this webinar, you will learn about:
  • Challenges arising from high concentrated protein formulations
  • The viscosity reduction platform: a portfolio of excipients to manage protein viscosity
  • The impact of viscosity reducing excipients on protein stability
  • The impact of protein viscosity on syringability
Detailed description:
Subcutaneous (subQ) administration can improve patient convenience and reduce healthcare costs by avoiding the need for hospitalization. Yet in some cases, high protein concentrations make formulations far more viscous, prohibiting this route of administration. While viscosity can normally be reduced by using certain excipients, merely adding more and more of a single excipient may not bring sufficient improvement and can even compromise protein stability. This webinar will introduce an excipient platform that makes it possible to combine excipients in ways that can reduce protein viscosity to a greater extent.

Speaker:
Speaker
Tobias Rosenkranz, Ph.D.
Merck
Senior Manager, Biomolecule Formulation R&D
 
 
 
 

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Keeping the (Adventitious) Virus Out of the (Adeno-Associated) Virus

Subcategory: Downstream
Duration: 1 hour
Date: 12 August, 2021

In this webinar, you will learn about:
  • AAV process flows and focus areas for viral safety
  • Strategies for implementing viral clearance measures in bioprocessing
  • Case studies and data driven approaches on log reduction values (LRV) in a viral vector process
  • Best practices and evaluation roadmaps on conducting viral clearance studies
Detailed description:
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?

Gene delivery using AAV has received a boost from two major approvals and the nearly 300 programs in the clinic. Novel gene therapies using viral vectors enable companies to transform the lives of people living with certain rare and ultra-rare diseases where treatments are often not available currently. Amongst a multitude of challenges in viral vector bioprocessing, uncertainty in regulatory expectations is a major challenge to gene therapy developers. Regulatory requirements are evolving as the science and manufacturing matures with more stringent measures for viral safety assurance expected for future approvals.

Learn how to implement techniques for adventitious virus removal in your viral vector process; we will focus on strategies for viral clearance along your journey towards commercial readiness of AAV-based processes.

Speaker:
Speaker
Ratish Krishnan
Merck
Senior Strategy Consultant, Novel Modalities Bioprocessing
 
 
 
 

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Make it Right: Best Practices for mRNA Manufacturing

Subcategory: Downstream
Duration: 1 hour
Date: 8 July, 2021

In this webinar, you will learn:
  • Therapeutic potential of mRNA: COVID-19 and beyond
  • How mRNA manufacturing workflows and facility design have a significant impact on reproducibility and performance
  • Amptec capabilities to accelerate mRNA development and manufacturing
Detailed description:
How do you define a strategy for viral clearance for a process that inherently aims at purifying a virus?

The success of mRNA-based COVID-19 vaccines has created a significant level of interest in this versatile biomolecule for disease prevention and treatment. While production of these vaccines took place in record time, critical decisions must be made when developing novel mRNA applications to ensure manufacturability, reproducibility, and safety.

This webinar will explore foundational elements of the mRNA manufacturing workflow and strategies to design the right facilities to ensure success. Topics include collaborative approaches to ensure access to high quality raw materials, application of advanced technologies for manufacturing, options for facility design and key considerations when leveraging a contract development and manufacturing partner.

Speakers:
Speaker
Nargisse El Hajjami, Ph.D. Eng.
Merck
Senior Consultant, Bioprocessing Strategy Operationalization, EMEA, Novel Modalities & mRNA
Speaker
Shiksha Mantri, Ph.D.
Merck
Global Marketing Manager, RNA Solutions

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Single-Use Tangential Flow Filtration for Closed Processing

Subcategory: Downstream
Duration: 1 hour
Date: 6 May, 2021

In this webinar, you will learn:
  • The context of closed processing
  • Differences between closed and functionally closed processing
  • The drivers for adoption
  • Its practical implementation to a TFF step
Detailed description:
Closed processing with single-use technologies is a critical enabler for efficient and robust manufacturing for novel modalities as well as continuous biomanufacturing processing. It can also reduce the dependence on classified clean rooms for traditional modalities. This approach helps to mitigate the risk of contamination by adventitious agents while enhancing operator safety.

In this presentation, we discuss the implementation of closed processing for downstream applications and present the design and performance testing of a single-use manufacturing-scale tangential flow filtration system to be able to operate in both functionally and fully closed mode.

Speakers:
Speaker
Dana Kinzlmaier
Merck
Applications Engineer
Speaker
Sarah Le Merdy
Merck
Strategy Deployment, Single-Use and Systems

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Subcategory: Formulation

Polyvinyl Alcohol: One Polymer, Multiple Solutions for Oral Solid Dosages

Subcategory: Formulation
Duration: 1 hour, 30 minutes
Date: 15 January, 2024

In this webinar, you will learn:
  • How to master consistent drug delivery over long release periods by the use of PVA in sustained release formulations
  • How to tackle challenges with poorly APIs by the use of hot melt extrusion, spray drying and 3D printing technologies
  • How high process efficiency and stable granules can be achieved with PVA as a binder for wet granulation in continuous manufacturing
  • How PVA can be effectively used in orodispersible film applications enabling a rapid dissolution of the API and easy intake by patients
Detailed description:
During formulation development of oral solid dosage forms, complex challenges such as instability of APIs and API processing are on the rise. Due to its various functionalities the multi-talent polyvinyl alcohol (PVA) offers effective solutions to these challenges. Beyond classical applications as a matrix polymer or coating component, the versatile polymer can be effectively used in orodispersible films and is well suited for hot melt extrusion, spray drying, continuous manufacturing and 3D printing technologies.

This webinar provides you with technical insights on how PVA can be used in a broad range of solid applications to meet future trends in formulation development.

Speakers:
Speaker
Markus Lubda, Ph.D.
Merck
Strategic Business Manager
Speaker
Lena Mueller
Merck
Senior Laboratory Manager

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Thermostabilizers: Protecting Vaccines Upon Cold Chain Breaks

Subcategory: Formulation
Duration: 36 minutes
Date: 5 October, 2023

In this webinar, you will learn:
  • About the challenges involved in the delivery of vaccines to developing countries and potential risks
  • How using conventional and new excipients can stabilize protein vaccines in liquid and in solid vaccine formulations upon short-term cold chain breaks
Detailed description:
The delivery of liquid and solid vaccine formulations to developing countries entails several challenges, one of which being cold chain breaks. Short-term exposure to higher temperatures of up to 50 to 80°C results in a large proportion of these vaccines to be wasted each year. It is in the interest of patients and manufacturers alike as the latter faces the financial risk of wasted vaccines. Additionally, approval of new vaccines is restricted due to the pressure on the supply chain.

Therefore, we asked ourselves: How can we stabilize protein vaccines in liquid and solid formulations towards these temperature increases using conventional and new excipients?

Speakers:
Speaker
Michelle Pascale Zoeller, Ph.D.
Merck
Senior Scientist
 
 
 
 

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Envisioning New Concepts for Pharmaceutical 3D Printing and Solubility Enhancement

Subcategory: Formulation
Duration: 1 hour
Date: 26 September, 2023

In this webinar, you will gain:
  • Latest insights in 3D printing technogies for oral drug delivery
  • An in depth understanding of advanced functionalities created by combining a commercial scale 3D printing manufacturing technology with a solubility enhancement platform
  • Insights into the SoluPrint manufacturing concept
  • New ideas on how advanced manufacturing concepts can benefit your product development
Detailed description:
In this webinar, we will introduce a new concept for additive manufacturing of challenging oral dosage forms. Combining Aprecia's commercial-scale 3D printing platform with our latest solubility enhancement technolgy we are envisioning new manufacturing opportunities for formulation developers. Especially in cases where polymorphism or particle properties are inconsistent throughout development, our technology based on Parteck® SLC silica carrier can provide a new manufacturing alternative by creating 3D printed oral solid dosage forms either utilizing pre-loaded carrier material of by direct loading of the carrier during the 3D printing process.

Speakers:
Speaker
Thomas Kipping, Ph.D.
Merck
Head of Drug Carriers
Speaker
Michelle Schilling, Ph.D.
Merck
Product Development Manager

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How to Prevent Protein Aggregation through Stabilizers and Surfactants

Subcategory: Formulation
Duration: 1 hour
Date: 31 August, 2023

In this webinar, you will learn:
  • About mechanisms involved in the formation of protein particles
  • Why different classes of excipients are required to prevent protein aggregation
  • About our novel surfactants/stabilizers and their capability to overcome challenges associated with protein instability
Detailed description:
Aggregation of therapeutic proteins can occur during all steps of drug product manufacturing and handling. One option to efficiently prevent protein aggregation in solution is the application of excipients. Depending on the underlying mechanism of protein aggregation, different classes of excipients such as stabilizers and surfactants are required to stabilize the protein. Stabilizers enhance protein stability in the bulk whereas surfactants efficiently prevent agitation- and surface-induced protein aggregation.

This webinar will provide a comprehensive overview of protein aggregation, underlying mechanisms and stabilization techniques using (novel) excipients in parenteral formulations.

Speakers:
Speaker
Michelle Pascale Zoeller, Ph.D.
Merck
Senior Scientist
Speaker
Can Araman, Ph.D.
Merck
Senior Manager, Lab Head

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Strategies and Enabling Technologies for Enhancing API Solubility

Subcategory: Formulation
Duration: 1 hour, 34 minutes
Date: 4 April, 2023

In this webinar, you will learn:
  • About the Developability Classification System (DCS)
  • Why it is important to distinguish between dissolution and solubility limited molecules
  • Recomended strategies for dissolution enhancement of DCS Class IIa compounds and solubility enhancement of DCS Class IIb compounds
Detailed description:
Development of new active pharmaceutical ingredients (APIs) is lengthy and cost-intensive, thus avoiding any potential risk that may limit the product's success is of utmost importance. Today, many APIs are not being commercialized as they are poorly water soluble and, as a result, exhibit too low bioavailability.

The Developability Classification System was developed to assist formulation scientists by introducing two new compound categories: Dissolution rate limited (DCS IIa) and solubility limited (DCS IIb). Depending on where your API lies, there are various strategies to optimize formulation of poorly soluble molecules - From particle size reduction, to solid state modification, to API processing techniques like salt and cocrystal formation.

Speakers:
Speaker
Michelle Pascale Zoeller, Ph.D.
Merck
Marketing Manager, Excipients Liquid Application
Speaker
Markus Lubda, Ph.D.
Merck
Strategic Marketing Manager - Excipients Solid Application

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Envisioning New Concepts for Pharmaceutical 3D Printing and Solubility Enhancement

Subcategory: Formulation
Duration: 1 hour
Date: 30 March, 2023

In this webinar, you will learn:
  • Key considerations to select the right lipid excipients
  • The process development steps to bring a LNP formulation to GMP manufacturing and clinical trials
  • More about our Millipore® CTDMO services, from mRNA to lipids and LNPs manufacturing
Detailed description:
Covid-19 vaccines have demonstrated the clinical potential of mRNA-Lipid Nanoparticle formulations. To enable the development of next-generation lipid-based drug delivery systems, expertise and manufacturing capabilities are critical.

Relying on more than 20 years experience in GMP lipid/LNP manufacturing, we aim at supporting pioneers in nucleic acid modalities to bring life changing medicines from preclinical to commercial manufacturing.

Speakers:
Speaker
Mahesh Karwa
Merck
Associate Director, Process Development
Speaker
Teresa Demuth
Merck
Strategic Marketing Manager

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Formulation and Predictive Technologies to De-risk Solid-state Variation in Drug Development

Subcategory: Formulation
Duration: 1 hour
Date: 15 November, 2022

In this webinar, you will learn:
  • The Importance of solid form in the development of orally delivered dosage forms
  • How Crystal Structure Prediction (CSP) can be used to optimize solid form and identify challenging molecules
  • Why mesoporous silica is an attractive formulation technology to homogenize particle properties
  • About the combination of predictive and formulation technologies as a platform approach to solid formulation development
Detailed description:
This webinar will present the concepts of crystal structure and polymorphism in drug development of Oral solid dosage forms, will introduce CSP as an option to minimize solid-state risks and, finally, will describe how mesoporous silica can be used as a last-resort technology to homogenize a solid form from exhibiting polymorphism.

All of the above will be supported by a range of case studies from a diverse and highly relevant chemical space. Finally, we will propose an integrated workflow to combine computational and formulation technologies to optimize the development of orally delivered small molecules.

Speakers:
Speaker
Gudrun Birk
Merck
Head of Controlled Release
Speaker
Michael Belucci
XtalPi
Senior Director - Solid Form Design

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Overcoming Challenges in Ophthalmic Formulations with Right Quality of Excipients

Subcategory: Formulation
Duration: 1 hour
Date: 20 September, 2022

In this webinar, you will gain:
  • Challenges in ophthalmic formulation development
  • Selection of excipients for ophthalmic formulations
  • Risk Mitigation in ophthalmic formulations with Emprove® Program
Detailed description:
The formulation of ophthalmic drugs must address a unique combination of requirements. In addition to ensuring quality, drug tolerability and fostering patient compliance, formulators must also consider tonicity, viscosity, pH, stability, sterility and microbiological purity.

This webinar will address how to overcome common challenges in ophthalmic formulations with selection of right quality of excipients. Our GMP grade excipients are in line with ophthalmic industry standards and needs supported by Emprove® Program. Our Emprove® Program along with the Emprove® Expert portfolio range, combines comprehensive documentation with excellent service, to support risk assessment and qualification for your ophthalmic process.

Speaker:
Speaker
Smita Rajput, Ph.D.
Merck
Field Marketing Manager, India, SEA & Oceania
 
 
 
 

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Discover Excipients to Stabilize Your Biomolecule Formulation Using a Surfactant

Subcategory: Formulation
Duration: 1 hour
Date: 26 July, 2022

In this webinar, you will learn:
  • The role of surfactants as stabilizers in biopharmaceuticals
  • The advantages/disadvantages of using the various marketed surfactant in biomolecule surfactants
  • The impacts of impurities in excipients on the formulation stability
Detailed description:
A stable formulation is critical to ensure the desired therapeutic activity and safety of biologics. Mechanical stresses during manufacturing and transportation and certain storage conditions can lead to protein destabilization and aggregation. By minimizing interface interactions and increasing solubility, surfactants can stabilize proteins. Polysorbates have been the most widely used surfactants in biologics due to their biocompatibility and low toxicity. However, over the past decade challenges associated with the stability of polysorbates have been encountered. To reduce these quality issues, alternative surfactants, such as poloxamer 188 are considered in biomolecule formulations.

Speaker:
Speaker
Nelli Erwin, Ph.D.
Merck
Senior Manager, Head of Protein Stability
 
 
 
 

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Latest Advancements of Melt-based 3D Printing Technologies for Oral Drug Delivery

Subcategory: Formulation
Duration: 1 hour
Date: 23 June, 2022

In this webinar, you will learn:
  • Latest advancements of melt based 3D printing approaches
  • Application examples for the individual technologies
  • Deep dive in the MED® 3D printing technology to design dedicted drug release profiles
Detailed description:
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing.

Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented. The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures.

Speaker:
Speaker
Thomas Kipping, Ph.D.
Merck
Speaker Job Title
Speaker
Xianghao Zuo, Ph.D.
Triastek
Deputy Director of R&D

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Dissolution Enhancement of Poorly Soluble Drugs, Guided by the Developability Classification System

Subcategory: Formulation
Duration: 1 hour
Date: 24 May, 2022

In this webinar, you will learn:
  • About the Developability Classification System (DCS)
  • Why it is important to distinguish between dissolution and solubility limited molecules
  • How Poloxamers can be used to accelerate dissolution of poorly soluble molecules
Detailed description:
The Developability Classification System (DCS): A useful tool to optimize formulation of poorly soluble molecules. The DCS was developed to assist formulation scientist by introducing two new compound categories: Dissolution rate limited (DCS IIa) and solubility limited (DCS IIb). For DCS IIa molecules, particle size reduction and an addition of Parteck® PLX as a wetting agent can accelerate the dissolution. For DCS IIb molecules, solid-state modification via hot melt extrusion or carrier particles can be utilized. This webinar will introduce the concept underpinning this emerging field of research, which allows more targeted and optimized formulation development of poorly soluble compounds.

Speaker:
Speaker
Markus Lubda, Ph.D.
Merck
Strategic Marketing Manager
 
 
 
 

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The High Intensity Sweeteners Neotame and Sucralose: Two Ways to Ace the Patient's Taste Test

Subcategory: Formulation
Duration: 1 hour
Date: 26 April, 2022

In this webinar, you will gain:
  • How to optimize the patients´ taste experience of your pharmaceuticals
  • How sweeteners can be differentiated by their sensory profiles and features
  • How our new product offering Neotame can be effectively used in your targeted formulations
Detailed description:
Mask bitter aftertaste for a sweeter pill to swallow! Patients' compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects:
  • excellent sugar-like taste profile
  • outstanding sweetness factors
  • use effectiveness
  • enhanced stability


Tune in to our next webinar! We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception.

Speaker:
Speaker
Almut von der Brelie
Merck
Senior Manager Strategic Marketing Excipients for Solid Applications
 
 
 
 

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How a Helium Manufacturing Release Test Increases Integrity Assurance for Single-Use Assemblies

Subcategory: Formulation
Duration: 1 hour
Date: 31 March, 2022

In this webinar, you will learn:
  • Different approaches for integrity testing single-use systems
  • The benefits of the helium integrity test for increased integrity assurance in critical single-use systems
Detailed description:
Helium integrity testing is an industry-proven test that detects defects in single-use systems. This sensitive test reduces the risk of leaks or microbial ingress into manufacturing processes so manufacturers can be confident their entire systems, including tubing and connection points, are integral. This is especially critical during freezing, thawing, transportation and storage. This webinar will describe development and validation of the helium integrity test and demonstrate how it can benefit critical single-use process steps.

Speakers:
Speaker
Monica Cardona
Merck
Senior Program Manager
Speaker
Chuck Raye
Merck
Product Manager, Final Fill Single Use Systems

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Continuous Manufacturing - Issues and Answers

Subcategory: Formulation
Duration: 1 hour
Date: 16 November, 2021

In this webinar, you will learn:
  • The key issues in continuous manufacturing concerning excipients
  • How those issues can be addressed
Detailed description:
Continuous manufacturing is a major trend in solid dose formulation. It shows economic and quality benefits, however, hurdles and challenges need to be tackled before getting there. This webinar will address these hurdles and challenges as they relate to excipients.

We will present how continuous manufacturing lines are set up and the benefits users have experienced from them. Feeding of especially small components of formulation combined with bad flow is a major challenge, as well as having a high number of components leading to many feeders. Our answer to these challenges are threefold: betting on multifunctional excipients, and on premixes, either as finished products or as customized projects.

Speakers:
Speaker
Leo Ohrem, Ph.D.
Merck
Strategic Marketing Manager
 
 
 
 

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The Developability Classification System for Poorly Soluble Drug Formulation Strategies

Subcategory: Formulation
Duration: 1 hour
Date: 2 November, 2021

In this webinar, you will learn:
  • How the developability classification system (DCS) emerged from the well-established biopharmaceutics classification system (BCS)
  • How the DCS can distinguish between solubility and dissolution limited compounds
  • How particle size reduction and wetting agents can enhance dissolution of DCS IIa compounds
  • How solid-state modification can enhance solubility of DCS IIb compounds
Detailed description:
The developability classification system (DCS) was proposed as a modification of the BCS to assist in formulation of poorly soluble compounds. The DCS introduced two new compound categories: dissolution limited (DCS IIa) and solubility limited (DCS IIb). For DCS IIa molecules, particle size reduction and wetting agents can be considered. For DCS IIb compounds, solid state modification can be utilized. Tune in to our webinar on the developability classification system to learn more about this emerging field of research, which is allows more targeted and optimized formulation development of poorly soluble compounds.

Speakers:
Speaker
Daniel Joseph Price, Ph.D.
Merck
Strategic Marketing Manager
 
 
 
 

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The Role of Polyvinyl Alcohol (PVA) in Ophthalmic Formulations

Subcategory: Formulation
Duration: 1 hour
Date: 5 August, 2021

In this webinar, you will learn:
  • Different functions of polymers
  • How the DCS can distinguish between solubility and dissolution limited compounds
  • Unique properties of Poly-vinyl alcohol (PVA) relevant for ophthalmics
  • Best practices to handle PVA
Detailed description:
Polymers play an important role in ophthalmic formulations. However, it is difficult to select the best grade of polymer which provides the desired viscosity as well as ease in formulation development. This webinar will present case studies and benchmarking of various polymers commonly applied in ophthalmics, highlighting the importance of PVA and providing guidance for best practices to handle this polymer. PVA is a synthetic grade polymer with high batch-to-batch consistency available in different grades, low to high viscosity. It offers great opportunities for ophthalmic formulations as it can be used for different applications like lubrication, viscosity modification, stabilization and sustained release.

Speakers:
Speaker
Smita Rajput, Ph.D.
Merck
Field Marketing Manager, India, SEA & Oceania
 
 
 
 

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Excipients Selection for High Risk Formulation

Subcategory: Formulation
Duration: 1 hour
Date: 25 May, 2021

In this webinar, you will learn:
  • Different functions of polymers
  • How the DCS can distinguish between solubility and dissolution limited compounds
  • Unique properties of Poly-vinyl alcohol (PVA) relevant for ophthalmics
  • Best practices to handle PVA
Detailed description:
Polymers play an important role in ophthalmic formulations. However, it is difficult to select the best grade of polymer which provides the desired viscosity as well as ease in formulation development. This webinar will present case studies and benchmarking of various polymers commonly applied in ophthalmics, highlighting the importance of PVA and providing guidance for best practices to handle this polymer. PVA is a synthetic grade polymer with high batch-to-batch consistency available in different grades, low to high viscosity. It offers great opportunities for ophthalmic formulations as it can be used for different applications like lubrication, viscosity modification, stabilization and sustained release.

Speakers:
Speaker
Smita Rajput, Ph.D.
Merck
Field Marketing Manager, India, SEA & Oceania
 
 
 
 

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When Coating Runs Smoothly: Enhance your Coating Process with a new Particle Designed PVA

Subcategory: Formulation
Duration: 1 hour
Date: 20 May, 2021

In this webinar, you will learn:
  • How to create your coating formulation by utilizing a broad excipient toolbox
  • Potential advantages of PVA as a stable moisture and oxygen barrier to protect challenging drug substances
  • Creating the perfect surface finishing
  • How to utilize novel analytical technologies to boost your formulation development
Detailed description:
In film coating applications water soluble polymers like polyvinyl alcohol (PVA) take a unique position. PVA can be used in immediate release coatings and provides an exceptional moisture and oxygen barrier. A dedicated particle design allows rapid dissolving times and due to the low viscosities of PVA solutions high solid contents can be obtained leading to a high process efficacy.

The webinar will cover coating formulation development as well as novel technologies for characterization of coated tablets that can easily be implemented during production. Optical coherence technology (OCT) and laser scanning microscopy (LSM) can be valuable tools to assess the coating quality.

Speakers:
Speaker
Thomas Kipping, Ph.D.
Merck
Head of Drug Carriers
 
 
 
 

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Subcategory: Next Generation Bioprocessing

Conquering Bioreactor Process Control: From Cell-Free Optimization to Cell Culture Confirmation

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 5 September, 2024

In this webinar, you will learn:
  • Cell-free methods that were used to evaluate strategies for pH and DO control
  • How a new bioreactor technology was designed with integrated process control for high-performance and scalability
  • Examples of cell culture processes that were successfully executed in the Mobius® iFlex Bioreactor
Detailed description:
As the source of biotherapeutic production, the bioreactor is a crucial step for a successful bioprocess. Bioreactors must maintain precise control of environmental conditions to achieve optimal cell growth and productivity, requiring reproducible control strategies. The technology must be flexible and scalable to deliver consistent results from lab to manufacturing.

The Mobius® iFlex Bioreactor was developed to meet these requirements and deliver high performance for any process type, from fed-batch to high VCD perfusion. This presentation will demonstrate the system control capabilities in cell-free and cell-containing experiments, enabling successful upstream process outcomes.

Speaker:
Speaker
Haley Matthews
Merck
Applications Engineer III
Speaker
Gujie Mi
Merck
R&D Manager

Process Intensification of Monoclonal Antibody Purification Process

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 11 April, 2024

In this webinar, you will learn:
  • How to intensify capture by harvest preconcentration
  • How to intensify polishing by leveraging flowthrough polishing technologies
  • Leverage viscosity-reducing excipients, screens and SPTFF for high concentration formulation
Detailed description:
Process intensification of mAb purification offers a viable approach to boost productivity with minimal facility modification. This approach can also impart flexibility for handling multiple clinical and commercial programs with varying upstream titers.

We will provide an overview of an intensified monoclonal antibody purification process leveraging best in class purification technologies offered by us. We will present harvest preconcentration enabled intensified capture, intensified polishing via flowthrough polishing technologies and intensified drug delivery by leveraging viscosity reduction platform, cassette feed channel designs and Single Pass Tangential Flow Filtration (SPTFF).

Speakers:
Speaker
Akshat Gupta
Merck
Associate Director, Focused Modalities Applications
 
 
 
 

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Unleashing the Power of Perfusion: CHOZN® GS-/- Cell Line Development for Intensified Processes

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 21 March, 2024

In this webinar, you will learn:
  • How to optimize the CLD process to generate stable, high-performing, perfusion clones
  • How to incorporate perfusion scale-down models into your CLD workflow
  • How the Mobius® Breez can be used to make final clone selection and begin perfusion process development in a cost effective manner
  • The importance of using the right media for cell line expansion and production during CLD
Detailed description:
It is essential to select perfusion clones during cell line development (CLD) that thrive in the unique environment of intensified bioprocesses. Such clones have high specific productivity (qP), moderate growth rates, and high volumetric titer and yield. Traditional fed-batch CLD selects for clones that perform well in fed-batch, but this performance may not translate to a perfusion process.

Here, we highlight the advantage of adopting a perfusion-specific CLD process to create more productive clones and provide an integrated solution for intensified processing using the CHOZN® GS-/- cell line, a suite of best-in-class media, and the Mobius® Breez Microbioreactor system.

Speaker:
Speaker
Vince Balassi
Merck
Scientist III
 
 
 
 

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Modelisation and Real-Time monitoring of Glycosylation During mAb Manufacturing Process Using Raman Spectroscopy

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 7 March, 2024

In this webinar, you will learn:
  • How Raman spectroscopy will enhance your process monitoring capacities integrating high end CQAs (glycans)
  • How to assess model quality: accuracy and robustness
  • How to perform Raman measurment regardless of lab light environment
Detailed description:
This webinar presents a unique opportunity to delve into the convergence of cutting-edge technology and bioprocessing. Here, Raman spectroscopy stands out as a game-changer, unveiling the intricacies of glycosylation patterns in real time—an essential element in the manufacturing of monoclonal antibodies.

The use case highlighted in this webinar illustrates a methodology for building robust and proven glycan models, enabling real-time monitoring of the glycosylation profile. It opens new doors for tailoring and optimizing glycosylation patterns throughout the monoclonal antibody manufacturing process.

Speakers:
Speaker
Jérémy Peyrol
Merck
USP Innovation Expert - BioVV Innovation for Biologics
 
 
 
 

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PAT Implementation for ADC & Bioconjugation Processes: Applications and Case Studies

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 9 November, 2023

In this webinar, you will learn:
  • Benefits of in(on)line testing for conjugation processes
  • PAT implementation at different steps of conjugation process
  • Case studies for real-time monitoring by online HPLC
Detailed description:
With drug developers and manufacturers facing closer scrutiny on product quality than ever before, we as industry leading CDMO are continuously evolving process analytical technology to design robust and cost-effective control strategies and understand more about the characteristics of your ADC or bioconjugate.

In this webinar we will discuss pros and cons of in(on)line testing for conjugation process, highlight PATs at different steps and share advancements through case studies for real-time monitoring the reduction and conjugation process by online HPLC.

Speakers:
Speaker
Yiyi Li
Merck
R&D Scientist, ADC&LNP Template Innovation
Speaker
Mary Ramisetty
Merck
Senior Scientist Group Lead Process & Analytical Development

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The Closed Processing Advantage: Optimizing Biopharma Facilities

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 31 October, 2023

In this webinar, you will:
  • Understand the current market trends driving the need for closed processing in biopharma, including the rise of novel modalities, multi-product manufacturing, and the demand for more flexible facilities
  • Explore the benefits and value drivers of closed processing, including facility utilization, sustainability, cost reductions, and labor savings
  • Examine the evolution of biopharma facility design, comparing traditional layouts to innovative, modular, and ballroom-style configurations
  • Learn about industry efforts to harmonize guidance and best practices, fostering a collaborative environment for closed processing adoption
Detailed description:
Join us for an insightful webinar as we explore the future of biopharma facility design and operations. Discover the key market trends driving the need for single-use, closed processing solutions. Learn how closed processing can help you reduce costs, accelerate time to market, optimize facility utilization, and minimize risks.

Speakers:
Speaker
Sara Bell
Merck
Marketing Manager
Speaker
Alejandro Kaiser
Merck
Senior Process Engineer, Kaiser Global Engineering

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Enabling Upstream Intensified Bioprocessing with our New Mobius® iFlex Bioreactors

Subcategory: Next Generation Bioprocessing
Duration: 35 minutes
Date: 19 October, 2023

In this webinar, you will learn how our new single-use bioreactor family can help you:
  • Fulfill any process strategy, be it batch, fed-batch or perfusion
  • Facilitate scalability of your upstream process
  • Utilize the flexible design to reduce production costs
Detailed description:
Intensified upstream bioprocesses are being developed to increase productivity while reducing footprint, costs and timelines for manufacturing. The higher cell densities generated by intensification result in increased gassing and mixing requirements, to ensure a homogeneous cell culture environment with effective oxygenation and CO2 removal at all scales. The new Mobius® iFlex bioreactor, was developed with an expanded design space, providing flexibility for a variety of bioprocesses. Impeller and motor designs reach up to 100 W/m3 with <35 second mixing time while maintaining tip speeds under 2.2 m/s and innovative spargers achieve kLa of >50 hr-1.

Speaker:
Speaker
Samantha Whitney
Merck
Applications Engineer
Speaker
Kristen Der
Merck
Associate Product Manager

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Monitoring and Quality Control of Cell Culture Media Preparation using Raman Spectroscopy

Subcategory: Next Generation Bioprocessing
Duration: 35 minutes
Date: 2 March, 2023

In this webinar, you will:
  • Learn about new possibilities for using Raman technology
  • Discover uses and benefits of Raman technology in quality control of cell culture media preparation
Detailed description:
Process Analytical Technologies (PAT) are used to measure Critical Process Parameters (CCPs) which affect Critical Quality Attributes (CQAs). They are therefore particularly interesting for better process knowledge and control. Raman spectroscopy has already demonstrated very good results in real-time monitoring of main parameters of cell cultures. This technology could also be used in other steps of a manufacturing process.

In this webinar, we will explore the possibilities of using Raman spectroscopy for quality control of cell culture media preparation. We will discuss the benefits of using this technology at this step and the demonstrated performances.

Speaker:
Speaker
Nathan Gay
Merck
Bioprocess Applications Engineer
 
 
 
 

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Closed Concept for Biopharmaceutical Manufacturing

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 29 November, 2022

In this webinar, you will:
  • Closed System/s Definition
  • Regulations around Closed Processing
  • Technologies that enable Closed Processing
  • Closed Systems in Downstream & Final Filling areas
Detailed description:
Innovations in bioprocessing equipment design and operation are reaping higher efficiency through “closed systems”, a concept largely made possible by single-use systems. These connect unit operations and isolate the process from the environment and operators, enabling shorter processing times, greater flexibility, more efficient site layouts and reduced costs. While widespread adoption has not been attained, COVID-19 has accelerated the industry's consideration of single-use and closed processing.

Join us to uncover the benefits and challenges of being closed processing ready in bioprocessing, and understand how this achieves better patient safety and care.

Speaker:
Speaker
Somasundaram G
Merck
Senior Consultant, Global Biopharm Center of Excellence
Speaker
Ashok Kumar N.
Merck
Head - Customer Application, Single Use and Integrated Systems, APeC
Speaker
Bennett Tan
Merck
Regional Strategy Execution Manager, SU&IS
 
 
 
 

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Integration of On-line HPLC as a PAT Tool for CQA Monitoring and Control in Bioprocessing

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 17 November, 2022

In this webinar, you will learn:
  • How Process Analytical Technology (PAT) tools can facilitate progress towards Biopharma 4.0 and real time release
  • Regulations around Closed Processing
  • How on-line HPLC can be implemented in a bioprocessing environment
  • The application of on-line HPLC to monitor and control critical quality attributes in bioprocessing
Detailed description:
High-performance liquid chromatography (HPLC) is a proven tool for the analysis of critical process parameters (CPP) and critical quality attributes (CQA) of biotherapeutics. Historically, HPLC has been performed off-line, a process that can take days or weeks to complete. By moving HPLC to the manufacturing floor as an on-line Process Analytical Technology (PAT) tool, relevant data can be accessed in a matter of minutes.

In this webinar, we highlight an initial use case demonstrating the utility of on-line HPLC to monitor and control antibody aggregation levels in bioprocessing. The implementation of PAT enables continuous manufacturing and empowers industry progress towards Bioprocessing 4.0.

Speaker:
Speaker
Stacy Shollenberger
Merck
Senior Marketing Manager, Process Analytical Technologies
Speaker
Daniel Kutscher, Ph.D.
Agilent Technologies
Product Manager, Strategic Marketing

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Utilization of Automated Aseptic Sampling for Accelerated Access to Process and Quality Data in Upstream Bioprocessing

Subcategory: Next Generation Bioprocessing
Duration: 45 minutes
Date: 27 October, 2022

In this webinar, you will learn:
  • The benefits of automated sampling to the upstream lab
  • How automated sampling can accelerate access to critical process parameters (CPPs) and critical quality attributes (CQAs)
  • How automated sampling complements in-line technologies to expand the capabilities for automated measurement of CPPs and CQAs
Detailed description:
Innovations in process analytical technologies (PAT) are helping to provide more comprehensive and earlier product and process monitoring and control capabilities. In this talk, we will focus on an automated sampling system and its utilization in perfusion cell culture for upstream process development.

We will demonstrate increased frequency of data acquisition for on-line measurement of CPPs and automation of a sample processing workflow to reduce the time to measure CQAs in perfusion cultures. Finally, we will discuss the impact of automated sampling to reduce manual labor, accelerate access to analytical data, and reduce risk in the upstream process.

Speaker:
Speaker
Allyson Caron
Merck
R&D Manager, Upstream Bioprocessing Applications
 
 
 
 

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Integration of Raman Spectroscopy for In-line and Real-time Monitoring of Critical Process Parameters and Quality Attributes in CHO Cell Perfusion Cultivation Modes

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 20 October, 2022

In this webinar, you will:
  • Discover case studies on the implementation of Raman spectroscopy soft-sensors for monitoring in bench-scale CHO cell intensified seed trains (N-1), steady state and dynamic perfusion(N) cultures
  • Understand the value of combining automated sampling with Raman spectroscopy for increased sample frequency, leading to more accurate measurement of CPPs and CQAs in the upstream bioprocess
Detailed description:
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration as a mechanism to design, analyze, and control biologic manufacturing processes through the measurement of critical process parameters (CPPs) which affect critical quality attributes (CQAs). The goal of PAT is to have quality built into the process, quality by design (QbD), for better process understanding and control.

Raman spectroscopy provides a great potential for real-time and in-situ measurement of relevant cell culture process parameters and product quality attributes. Consequently, upholding the QbD initiative.

Speakers:
Speaker
Rakesh Bobbala
Merck
Applications Engineer
 
 
 
 

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Effective Implementation of Multi Column Chromatography

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 28 June, 2022

In this webinar, you will learn:
  • The definition of multi-column chromatography
  • How MCC differs from standard chromatography in practice
  • System design, concerns and constraints
  • Use case on a process scale implementation
Detailed description:
Multi-column chromatography is a bioprocessing technique where multiple columns are loaded in series and then cycled for elution, regeneration and equilibration. This allows fuller utilisation of the potential resin binding capacity, rapid cycling of much smaller columns and with careful scheduling a continuous elution stream suitable for continuous or connected bioprocessing applications.

Whilst very effective at increasing operational efficiency, especially with Protein A primary capture of monoclonal antibodies, this technique does present challenges regarding system design, automation and control due to the increased complexity of the single-use flow path.

Speakers:
Speaker
Paul Beckett, Ph.D.
Merck
Senior Manager, Downstream Technologies, BioContinuum™ Platform
Speaker
Somasundaram G
Merck
Senior Consultant, APAC, Biopharm CoE

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CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes and Other Key Steps

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 9 June, 2022

In this webinar, you will:
  • Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
  • Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
  • Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Detailed description:
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed. This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.

Speakers:
Speaker
Benjamin Ross-Johnsrud
Merck
Speaker Job Title
Speaker
Robert Scott
Merck
Speaker Job Title

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Leveraging Next Generation Raman PAT Platform for Real-Time Bioprocess Monitoring

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 21 October, 2021

In this webinar, you will receive:
  • An introduction to Raman for bioprocess monitoring
  • An overview of PAT and real-time monitoring benefits
  • Practical case studies and applications for PAT
  • A live demo and overview of our Raman PAT Platform - ProCellics™ Raman Analyzer with Bio4C™ PAT Raman Software
Detailed description:
Mammalian cell cultures are widely used as the workhorse platform in the production of biological products such as antibodies or other therapeutic proteins. Deviations of critical process parameters (CPP) in upstream operations can directly lead to physicochemical and biological heterogeneities in the biological expression system and associated critical quality attributes (CQA) in therapeutic products. Hence, Process Analytical Technologies (PAT) represent an enabler to the Quality by Design (QbD) paradigm to generate adaptive processes that can maintain productivity and reduce product quality deviations through the implementation of process monitoring and control sensors.

Speakers:
Speaker
Hemant Garg
Merck
Bio4C™ ProcessPad & Analytics Product Manager
Speaker
Kevin Grollier
Merck
PAT Implementation & Support Engineer

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Platform Technologies to Accelerate Novel Vaccine Development and Manufacturing

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 3 August, 2021

In this webinar, you will learn:
  • Benefits of platform technologies in vaccine development
  • Key considerations when deciding between platforms
  • Vaccine pipeline analysis and selected case studies
Detailed description:
The vaccine industry has undergone a revolution in technology resulting in a variety of novel therapeutic platforms that accelerate development and significantly reduce the duration for process optimization and scale-up. However, challenges in maintaining efficacy and improving process robustness remain. In this presentation, we present a comparison of these novel technologies, discuss key considerations for manufacturing and share selected case studies for platforms such as virus-like-particles, viral vectors, plasmid DNA, and mRNA platforms.

Speakers:
Speaker
David Loong, Ph.D
Merck
Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy
Speaker
Josephine Cheng
Merck
Senior Consultant, Core Modalities Asia Pacific, Bioprocessing Strategy

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Better Bioprocessing Efficiency Through Centralized Orchestration

Subcategory: Next Generation Bioprocessing
Duration: 1 hour
Date: 13 May, 2021

In this webinar, we will present how orchestration software:
  • automates processes and workflows to reduce manual tasks, human errors, and operating costs
  • provides monitoring & visualization of multiple remote unit operations
  • gives remote access to systems, recipes, reports, user accounts, and alarms from a centralized process dashboard
Detailed description:
In this talk we discuss how orchestration software improves bioprocessing efficiency through the centralized configuration and management of connected unit operations for process and workflow automation across the plant floor.

A browser-based software solution, Bio4C™ Orchestrator software connects to individual unit operations from a centralized orchestration layer for remote access to systems, recipes, reports, user accounts and alarms from a holistic process dashboard.
  • Features that facilitate 21 CFR Part 11 and Eudralex Annex 11 compliance
  • Centralized audit report creation and management
  • Centralized management of all user accounts and passwords
  • Seamless tech transfer across Pilot Scale, MSAT, and Commercial Production
  • Modular architecture allows customized and scalable
Speakers:
Speaker
Aniruddha Bose
Merck
Global Product Manager, Automation & Analytics
 
 
 
 

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Subcategory: Regulatory

Little Patients, Big Challenges: Developing Pediatric Formulations

Subcategory: Regulatory
Duration: 1 hour
Date: 13 June, 2024

In this webinar, you will learn:
  • about the latest regulatory trends and requirements in the EU and in the USA for pediatric formulations, particularly with regards to critical impurities like ethylene glycol and diethylene glycol
  • about important aspects for the selection of suitable excipients for oral formulations
  • how to develop child-friendly orodispersible mini-tablets and films for enhanced patient adherence
Detailed description:
In the webinar, you will gain insights in new requirements for the testing of high-risk components on the impurities diethylene glycol and ethylene glycol. In addition, case studies for child-friendly dosage forms will be presented.

Speakers:
Speaker
Almut von der Brelie
Merck
Senior Strategic Product Manager, Excipients Solid Application
Speaker
Markus Greulich
Merck
Strategic Product Manager, Excipients Liquid Application
Speaker
Lars Albermann, Ph.D.
Merck
Head of Pharma Registration and Regulatory Projects
 
 
 
 

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Navigating the Regulatory Landscape of mRNA-based Therapeutics

Subcategory: Regulatory
Duration: 1 hour
Date: 14 May, 2024

In this webinar, you will:
  • Understand the distinct regulatory categorizations of mRNA therapeutics in the European Union and United States
  • Learn about the advantages of an EU-based mRNA drug substance manufacturer
  • Gain insights into regulatory requirements for LNPs in mRNA-LNP formulation
Detailed description:
In recent years, RNA-based therapeutics, particularly siRNA and mRNA-based drugs, have revolutionized the field of medicine. In this webinar, we will delve into the categorization of mRNA-based therapeutics in the European Union and the United States and examine the manufacturing requirements for mRNA drug substances in each region. We will also gain insights into the benefits of these regional differences for mRNA drug product development, stay informed on the latest EU and US regulations impacting mRNA therapeutics, from drug substance to lipid nanoparticle (LNP) formulations. In addition, we will discuss how to stay ahead of the evolving regulatory landscape and discover opportunities for your mRNA drug development strategies.

Speakers:
Speaker
Oliver Daniel Schwich, Ph.D.
Merck
Regulatory Expert - LSS Regulatory Management
Speaker
Melike Uzun
Merck
Regulatory Expert - LS Regulatory Management

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What Do You Need to Do to Qualify a Single-Use Assembly?

Subcategory: Regulatory
Duration: 1 hour
Date: 15 February, 2024

In this webinar, you will learn:
  • Implementation of Single-Use Technologies
  • Single-Use user requirement specifications (URS)
  • Best practices for single use qualification including quality and regulatory documentation
Detailed description:
Single-use technology (SUT) is well established in all stages of bioprocess manufacturing, including upstream, downstream, and fill/finish unit operations. The implementation of SUT usually starts with development of the user requirement specification (URS). The end users at biopharmaceutical companies work closely with the supplier to select components and assemblies (standard or custom) to meet the application requirements. Single-use qualification and regulatory considerations can include properties such as physical, functional, biological, chemical and sterilization.

This webinar will discuss best practices for single use qualification including quality and regulatory documentation.

Speakers:
Speaker
Monica Cardona
Merck
Speaker Job Title
Speaker
Jessica Shea
Merck
Senior Program Manager Emprove® Program

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A Journey Worth Taking - An Easier Path to Process Change Management

Subcategory: Regulatory
Duration: 1 hour
Date: 14 December, 2023

In this webinar, you will learn:
  • Some process changes don't need approval
  • Understanding your change, how classification impacts reporting
  • How customers can benefit from their supplier's experience & data packages
  • How a ‘change mindset' supports confident decision making
Detailed description:
Change management is constant in most biomanufacturing organizations and often avoided due to perceived complexity. While changes are necessary, they can also offer the opportunity to improve process control, efficiency, or costs. In this webinar, we describe a scientific, risk-based approach to change management and a roadmap for biomanufacturers to expedite changes in their post approval processes.

Suppliers have extensive product testing information and experience with implementing both process and product changes. By partnering with a collaborative supplier, you can leverage their support to streamline risk assessments and the change management process aligned with ICH Q12 guidance.

Speakers:
Speaker
Janmeet Anant, Ph.D.
Merck
Senior Regulatory Consultant
Speaker
Pascale Richert
Merck
Validation Services Consultant

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Applying Next Generation Sequencing for Adventitious Virus Detection

Subcategory: Regulatory
Duration: 1 hour, 30 minutes
Date: 12 December, 2023

In this webinar, you will learn:
  • The regulatory drivers and worldwide initiatives behind the movement to NGS based virus testing methods
  • How the methodology and bioinformatics is validated for its intended purpose and applied in the highly regulated GMP environment
  • Hear about real life case studies showcasing the use of the technology to ensure virus safety in biological products
Detailed description:
Next Generation Sequencing (NGS) technology has taken center-stage on the world platform as suitable alternative methodology to traditional broad virus safety screening in biologically derived products as both the industry and regulators progress initiatives to replace, reduce and refine (3Rs) animal testing. Global industry and interest groups have been working for over a decade to demonstrate suitability of the technology to serve as a primary virus screening method.

As a result, NGS based methods have been used for virus detection for many years to ensure the safety of both clinical and commercial products and recent updates to the ICH Q5A virus safety guidance encourage the use of NGS as a replacement for in vivo and in vitro adventitious testing methods.

The revised guidelines provide the expectations of a well-validated method that can be used for the detection of known and unknown viruses. In this presentation we will discuss the drivers behind the use of the technology, our approach at the validation of an NGS-based adventitious agent method, and the robust bioinformatic analysis that make it all possible.

Speakers:
Speaker
Bradley Hasson
Merck
Director of Lab Operations for NGS Services
Speaker
Leyla Diaz
Merck
Principal Scientist

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Pioneering eData Exchange for Quality and Regulatory Data with StaQRD™

Subcategory: Regulatory
Duration: 1 hour
Date: 17 October, 2023

In this webinar, you will learn:
  • How an eData standard will improve and streamline the process between supplier and manufacturer
  • What exactly StaQRD™ is and how it will impact the pharmaceutical industry
  • The technical prerequisites for machine readable content and how this can be exchanged between suppliers and manufacturers
Detailed description:
Embrace a data revolution with the newly developed StaQRD™ eData Standard, driving supplier selection, risk assessment and agile decision-making. The collaboration of BASF Pharma Solutions and Merck KGaA, Darmstadt, Germany unveils StaQRD™, an innovative eData standard, streamlining transfer of quality and regulatory data. Current challenges of diverse data formats are addressed, ensuring efficiency through universal eData compatibility.

Discover a new era of streamlined communication and automation, enhancing industry collaboration.

Speakers:
Speaker
Sebastian Aurich
Merck
Global Regulatory & Quality Compliance, BASF Pharma Solutions
Speaker
Stefan Brohm
Merck
Manager Digital Products
Speaker
Andreas Hildesheim
Merck
Senior Global Product & Marketing Manager, BASF Pharma Solutions
Speaker
Marius Stoffels
Merck
Product Owner - Digital Solutions

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Nitrosamine Method development Approach Inline with the EMA Guideline Published on 30 March 2020

Subcategory: Regulatory
Duration: 1 hour
Date: 12 October, 2023

In this webinar, you will learn:
  • Overview about the root causes that led to Nitrosamine contaminations in APIs
  • Update on Regulations and latest developments in the Pharmacopoeias IP, Ph. Eur., and USP
  • Discussion about method development requirement which will be inline with the EMA guideline publish on 30th March 2023
  • Selection of the right technique based on the Impurity and drug substance/drug product.
  • Understand the Ionization and the instrumentation parameter column selection which will help to achieve the lower LOD and LOQ of the Nitrosamine impurity
Detailed description:
The European Medicines Agency (EMA) initiated a request to Marketing Authorization Holders to identify products at risk of N-nitrosamine formation or contamination and to report the outcome. Several other regulatory agencies started similar approaches. Nitrosamine impurities continues to be a topic of concern among regulatory agencies and manufacturers and this webinar will review regulatory updates on this topic and focus on Method development approach inline with the EMA guidelines.

Speakers:
Speaker
Saroj Varavadekar, Ph.D.
Merck
Head of Regulatory Management, India
Speaker
Pramod Kadam, Ph.D.
Merck
Analytical/Quality Control, India

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Refresher on Excipient Regulations and Processes to Facilitate Drug Product Registration in China

Subcategory: Regulatory
Duration: 1 hour
Date: 15 August, 2023

In this webinar, you will learn:
  • How to navigate the registration and co-review process of excipients in China timely
  • How to deal with excipient related challenges during drug approval process in China
  • How significant ChP advocacy is
Detailed description:
The registration and co-review process in China and ensuring the use of ChP (Chinese Pharmacopoeia) compliant excipients can appear complex and time-consuming. With years of experience and regulatory expertise in China, we will provide an update on implementation of the excipient co-review procedure and reflect on importance of the same during drug approval process. We will expand upon the process of ChP advocacy and share learnings as we encountered challenges.

Finally, we will deep dive into regulatory trends for excipients in China including ICH (International Council for Harmonisation) guidance status and microbial requirements for excipient use in sterile and non-sterile drug products.

Speakers:
Speaker
Yuwei Heinzel
Merck
Head of Pharma Registration Germany
Speaker
Cloris Tian
Merck
Senior Regulatory Manager, Greater China

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Evaluating USP <665> for Extractables testing and reducing animal testing for Biological Reactivity

Subcategory: Regulatory
Duration: 1 hour
Date: 18 July, 2023

In this webinar, you will learn:
  • About USP <665> Extractable Requirements for pharmaceutical manufacturing
  • Risk Assessments for Extractables & Leachables
  • Updates to Biological Reactivity Testing and reducing Animal testing
Detailed description:
Evaluating Extractables & Leachables and performing a risk based approach is a key step for single-use manufacturing. With USP <665> approval in 2021, transitioning to this new standard is ongoing for polymeric material used in single-use manufacturing.

Animal welfare and reducing animal testing is also a key initiative. Biological reactivity testing has traditionally used both in vitro and in vivo methods. With the updates to the USP chapters, positioning cell-based assays of USP <87> and ISO 10993-5 as the primary method for determing Biological reactivity.

In this webinar, you will learn about the new and changing compendial methods and what it means for pharmaceutical manufacturing.

Speakers:
Speaker
Jessica Shea
Merck
Senior Program Manager - Emprove® Program
Speaker
Katharina Christlieb
Merck
Senior Marketing Operations Manager

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How to Leverage the ICH Q5A Guidance to Implement the Next Generation of QC testing

Subcategory: Regulatory
Duration: 45 minutes
Date: 14 March, 2023

In this webinar, you will learn:
  • Highlights of the draft revision
  • Updated testing strategies for key process steps in biologics manufacturing, based on the ICH Q5A revision
  • The benefits of modified testing packages
  • How to ensure regulatory acceptance
Detailed description:
In a short survey of the industry, concerns were raised about uncertainty regarding the implementation and consequent regulatory acceptance. This presentation will discuss the strategies for implementation of NGS and PCR-based tests at different steps of the manufacturing process and the requirements for regulatory acceptance.

Speakers:
Speaker
Manjula Aysola
Merck
Senior Regulatory Consultant
 
 
 
 

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Best Practices of pDADMAC Flocculation for a Successful GMP Biomanufacturing

Subcategory: Regulatory
Duration: 1 hour
Date: 28 March, 2023

In this webinar, you will learn:
  • Design of Experiments for pDADMAC use in GMP biomanufacturing
  • Risk assessment strategies for pDADMAC use in GMP biomanufacturing
  • Clearance testing of residual pDADMAC for GMP manufacturing
Detailed description:
High cell density culture is the new standard for the biopharmaceutical manufacturing process, but these feed streams can introduce major clarification challenges, such as high cell-based impurities, which foul traditional depth filters and reduce the capacities on further purification process. pDADMAC is a promising solution, yet its use in GMP biomanufacturing requires clarification.

This webinar addresses an overview on key aspects about, Quality by Design (QbD), Design of Experiments (DoE), Risk assessments based on ICH-Q3A and clearance test of pDADMAC use for GMP biomanufacturing, and provide you with a vital mindset to use pDADMAC into your GMP biomanufacturing process.

Speakers:
Speaker
Yuki Tsunakawa
Merck
Downstream Technical Application Expert
Speaker
Takuro Hozumi
Merck
Process Development Scientist

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The Future of Pharma- and Biopharmaceutical Audits

Subcategory: Regulatory
Duration: 45 minutes
Date: 4 August, 2022

In this webinar, you will learn:
  • Regulatory overview of remote audits
  • The technologies needed to support the audit process
  • What types of inspections are possible with the use of these technologies
  • How audits may look in the future
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.

Speakers:
Speaker
Daniel Buescher
Merck
Product Manager - Digital Solutions
 
 
 
 

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Regulatory Considerations including Extractables & Leachables for Single-Use Manufacturing

Subcategory: Regulatory
Duration: 1 hour
Date: 2 August, 2022

In this webinar, you will learn:
  • Regulatory Guidance for Single-Use Manufacturing
  • Risk Evaluation for Single-Use Implementation
  • Extractables and Leachables considerations using industry guidance
Detailed description:
SA successful adoption of single use technology in a Biopharmaceutical process largely relies on the confidence in selection of such materials. Understanding the regulatory and industry expectations are important to streamline the implementation and approval process.

This presentation will go through the regulatory expectation for single-use manufacturing and demonstrate the key benefits of the Emprove® Program including extractables data generated following the guidelines recommended by BioPhorum (BPOG) and adopting the USP <665> guidance. With a case study, a risk assessment process will be used to evaluate Extractables and Leachables requirements in a typical drug manufacturing process.

Speakers:
Speaker
Jessica Shea
Merck
Emprove® Program Manager
Speaker
Jayesh Parkar
Merck
Regional Strategy Execution Manager, Single Use Technologies

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Single-Use Systems - A Prerequisite for Closed Processing in Final Filtration and Filling Operation

Subcategory: Regulatory
Duration: 1 hour
Date: 12 July, 2022

In this webinar, you will learn:
  • Regulatory expectations when implementing and using single-use systems
  • Quality control of single-use systems - shift of responsibility from end-user to supplier
  • How single-use systems enable closed processing
Detailed description:
The rapid expansion in biopharmaceutical manufacturing capacity has increased the demand for SUS. Key drivers are flexibility, quick changeover of equipment, and reducing the risk of contamination when operating as closed systems. Join us to learn about regulatory expectations when implementing SUS.

Speakers:
Speaker
Simone Biel, Ph.D.
Merck
Senior Regulatory Consultant, Regulatory Affairs
 
 
 
 

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Risk-Based Qualification of X-Ray Sterilization for Single-Use Systems

Subcategory: Regulatory
Duration: 1 hour
Date: 5 May, 2022

In this webinar, you will learn about:
  • The comparison of gamma and X-ray irradiation sterilization
  • A risk-based qualification test strategy
  • Data evaluation of gamma versus X-ray sterilized single-use components
Detailed description:
The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods.

Speakers:
Speaker
Monica Cardona
Merck
Global Senior Program Manager
Speaker
Paul Killian, Ph.D.
Merck
R&D Director, Analytical Technologies

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EU GMP Annex 1 Draft - Closed System Design Consideration with Single Use Systems

Subcategory: Regulatory
Duration: 1 hour, 12 minutes
Date: 26 April, 2022

In this webinar, you will learn:
  • What are the EU GMP Annex 1 draft expectations on the use and control of single-use systems
  • Which measures to take assuring the integrity of a single-use system
  • How collaboration between supplier and end-user can support a risk based Contamination Control Strategy
Detailed description:
Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. During this webinar we will focus on points to consider assuring sterility and integrity of a single-use assembly, and how collaboration between supplier and end-user can support the overall contamination control strategy of final filtration and filling operation.

Speakers:
Speaker
Somasundaram G
Merck
Senior Consultant, APAC, Biopharm CoE
Speaker
Simone Biel, Ph.D.
Merck
Senior Regulatory Consultant

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Regulatory Talks: Finalization of USP 665

Subcategory: Regulatory
Duration: 1 hour
Date: 17 February, 2022

In this webinar, you will:
  • Understand details regarding the first official compendial general chapter, USP 665 for plastic components and systems used in drug manufacturing
  • Learn about the scope and justification to help you eliminate the need for previous testing methods which are no longer directly relevant
  • Leverage expert knowledge and regulatory support to plan the best approach to transition to this new USP 665 compendial extractables testing standard
Detailed description:
The Principle Scientific Liaison from the United States Pharmacopeia (USP) will clarify details regarding the first compendial general chapter, USP 665, detailing a standard assessment and testing approach for qualification of plastic components and systems used in drug manufacturing. This discussion will focus on the shift to this new approach and the necessity to conduct previous compendial test methods.

The expert panel will examine USP 665 in relation to other plastic qualification approaches. This discussion will include details regarding shifting away from USP 661, along with questioning the necessity of other related general chapter methods. Specifically, USP 661.1 and 661.2 will be highlighted, which are typically utilized for material characterization and drug packaging component characterization, respectively. In the end, you will be more confident in understanding what, how and when best to utilize the new compendial USP 665 standard extractables test methods.

Speakers:
Speaker
Desmond Hunt, Ph.D.
United States Pharmacopeia (USP)
Principle Scientific Liaison
Speaker
Monica Cardona
Merck
Senior Program Manager
Speaker
Janmeet Anant, Ph.D.
Merck
Senior Regulatory Consultant
 
 
 
 

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Regulatory Talks: Is USP 88, Class VI Animal Bioreactivity Testing Necessary for Plastics used in Manufacturing?

Subcategory: Regulatory
Duration: 45 minutes
Date: 16 December, 2021

In this webinar, you will:
  • Understand the USP objective to eliminate animal testing of plastics based on a risk-based decision making
  • Learn about the scope and justification to help you eliminate the need for animal testing of plastic materials used in pharmaceutical manufacturing
  • Leverage expert knowledge and regulatory support to find proven in vitro alternatives


The Principle Scientific Liaison from the United States Pharmacopeia (USP) will debunk myths regarding the risk of using plastics in pharmaceutical manufacturing systems. The specific test in question is USP 88 Class VI, Biological Reactivity Test performed on animals.

The expert panel will discuss this test in relation to other plastic qualification approaches. Based on the thousands of laboratory animals sacrificed and the millions of dollars wasted, USP 88, Class VI can no longer be justified in view of its unproven and questionable suitability to detect contaminants and increase safety. We will conclude with points on why animal testing will be seen by regulators as unwarranted.

Speakers:
Speaker
Desmond Hunt, Ph.D.
United States Pharmacopeia (USP)
Principle Scientific Liaison
Speaker
Monica Cardona
Merck
Senior Marketing Manager
Speaker
Janmeet Anant, Ph.D.
Merck
Senior Regulatory Consultant
 
 
 
 

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Regulatory Experience Sharing: Excipients for use in Lipid Nanoparticles

Subcategory: Regulatory
Duration: 38 minutes
Date: 4 November, 2021

In this webinar, you will learn about:
  • The regulatory classification of excipients
  • Purity and safety assessment of excipients for use in lipid nanoparticles
  • Specific and current regulatory requirements for lipid nanoparticles, liposomes and novel excipients
  • Emerging regulatory challenges


Excipients in lipid nanoparticles (LNP) can enhance the drug absorption or delivery and are thus of high interest in various therapeutic fields. However, the unique characteristics also pose regulatory challenges and exceed the authority’s expectations on data compared to other excipients. The purity and safety need to be demonstrated because of their crucial role in the function of the drug product and complex potential interactions with other ingredients or the physicochemical environment, for example. Thus, an overview of the regulatory excipient classification and the associated emerging regulatory challenges are presented for LNP, liposomes, and novel excipients.

Speakers:
Speaker
Claudia Widmann, Ph.D.
Merck
Regulatory Expert
 
 
 
 

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Risk-based Approach to Evaluate Nitrosamines and Elemental Impurities from Single-use Components

Subcategory: Regulatory
Duration: 1 hour
Date: 30 September, 2021

In this webinar, you will:
  • Understand of the potential of nitrosamine contamination
  • Learn how to leverage industry, supplier, and scientific expertise to assess the risk of elemental impurities taking advantage of ICH Q3D guidance on biologic drug manufacturing
  • See a case study using Emprove® Elemental Impurities to help you conduct an efficient elemental impurities safety evaluation D46


Residual impurities can potentially be introduced into the biopharmaceutical manufacturing process at a variety of stages. Recently, nitrosamines and elemental impurities have been a concern for regulatory agencies. These impurities originate from various raw materials, process chemicals and manufacturing equipment. Single-use systems (SUS) incorporate a number of plastic components. A key concern related to plastic SUS is potential leachable compounds from contact materials. It’s essential to obtain information on leachables as well as nitrosamines and elemental impurities. This webinar looks into how to evaluate nitrosamine and elemental impurity risk related to SUS and filters.

Speakers:
Speaker
Janmeet Anant
Merck
Senior Regulatory Consultant
Speaker
Jessica Shea
Merck
Emprove® Program Manager

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EU GMP Annex 1 Draft: Implications on Sterilizing Grade Filter Validation

Subcategory: Regulatory
Duration: 1 hour
Date: 16 September, 2021

In this webinar, you will learn:
  • About the GMP Annex 1 draft regulatory overview
  • How to incorporate the integrity testing & PUPSIT in the filtration systems validation
  • How to design a bacterial retention test in terms of organism selection and single vs multiple use validation


In this webinar we will discuss the implications of the EU GMP Annex 1 draft on the filtration of medicinal products and how this impacts the validation studies.

Bacterial Retention Testing is a critical part of the manufacturing validation process and is required by all regulatory bodies worldwide. Using case studies, our experts will explain how the Annex 1 draft is incorporated into the filtration systems validation exercise, specifically for integrity testing & PUPSIT (Pre-Use Post Sterilization Integrity Testing), the selection and justification of the appropriate test organism, and validation implications of single versus multiple use.

Speakers:
Speaker
Simone Biel, Ph.D.
Merck
Senior Regulatory Consultant
Speaker
Pascale Richert
Merck
Senior Validation Services Consultant

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PDA Virus Conference Follow Up: What to Expect with ICHQ5A (R2) for mAbs, CGT, and Beyond

Subcategory: Regulatory
Duration: 25 minutes
Date: 26 August, 2021

In this webinar, we share:
  • Acceptance of innovative technologies in biologics testing
  • Impact of ICHQ5A (R2) on therapy development and manufacturing
  • Advice from PDA and industry forums
  • Updated approaches to viral clearance


Recent advancements in bioprocessing have supported the accelerated growth of the biopharma industry. In response to these advancements, industry forums have focused on the need to minimize pathogen risk during biologics production amid calls for new process design, technologies, and detection strategies. The upcoming revision of ICHQ5A will include the use of new technologies and viral clearance strategies to also examine cell, gene therapies and newer vaccine paradigms such as virus like particles, subunit proteins, and viral vectors. This webinar will focus on presenting the impact on the industry from these updates.

Speakers:
Speaker
Manjula Aysola
Merck
Senior Regulatory Consultant
Speaker
Kathy Remington, Ph.D.
Merck
Technical Consultant

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Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and Tomorrow

Subcategory: Regulatory
Duration: 1 hour
Date: 15 July, 2021

In this webinar, we discuss:
  • Regulatory expectations of extractables and leachables assessment today and tomorrow
  • The right criteria that need to be assessed to select the type and quality of plastic materials for use in biopharmaceutical manufacturing


Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.

Since the USP 665 highlights a risk assessment approach with no typical pass/fail limit, approaches to decision-making based on the extractables data package will be reviewed. In addition, we will highlight legacy testing requirements which may not be necessary once USP 665 is implemented.

Speakers:
Speaker
Simone Biel, Ph.D.
Merck
Senior Regulatory Consultant
 
 
 
 

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EU GMP Annex 1 Draft – Implications on Filtration and Single Use Technology

Subcategory: Regulatory
Duration: 1 hour
Date: 8 June, 2021

In this webinar, you will learn:
  • Closed Processing and Single Use Technology implementation
  • Points to consider using Single-Use Technology
  • Sterile Filtration


Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.

The Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment. The second draft as of February 2020 was open for targeted consultation via stakeholders from selected industry organizations. The current Annex 1 draft emphasizes Contamination Control Strategy (CCS) multiple times and as a key consideration.

Speakers:
Speaker
Somasundaram G
Merck
Senior Consultant, Asia Pacific Global BioPharm CoE
Speaker
Simone Biel, Ph.D.
Merck
Senior Regulatory Consultant

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Subcategory: Software

There are currently no Software webinars. Please check back soon.

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Subcategory: Upstream

Driving the Evolution towards Intensified Upstream Processing

Subcategory: Upstream
Duration: 1 hour
Date: 14 December, 2023

In this webinar, you will learn:
  • Consideration for novel intensified upstream processing
  • Various intensification approaches from seed train to production
  • Ready to use, robust and scalable intensified upstream solutions
Detailed description:
In the current paradigm shift and transformation in biomanufacturing for a facility of the future, various approaches are being taken to realize a truly an ecosystem of intensified, connected & continuous processing seamlessly coupled with process analytical technologies (PATs). Intensified upstream processing offer a viable option for improving cell culture productivity enabling many operational benefits like process speed and facility utilization.

This presentation will summarize the current challenge and trends of upstream processing and describe the latest approaches for process intensification powered by PATs and Single-Use technology for closed processing.

Speakers:
Speaker
Takao Ito
Merck
Principal Consultant
Speaker
Sun-ha Song
Merck
Upstream Process Development Scientist

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A Single-use, Scale down, Predictive Solution for Intensified Perfusion Development

Subcategory: Upstream
Duration: 54 minutes
Date: 4 May, 2023

In this webinar, you will learn about:
  • The microbioreactor platform and its capabilities
  • Integrating the microbioreactor system for your media development workflow
  • Applying the technology to determine CSPR for specific cell lines
  • Predicting process scalability
Detailed description:
Perfusion is becoming a typical approach to achieving upstream process intensification. The ability to scale down these processes, however, has been limited due to lack of appropriate technologies. Labs cannot run enough bench scale 2L bioreactors with cell retention devices due to resource constraints (skilled labor and facilities) and high throughput systems lack the required perfusion or control capabilities.

This webinar describes a new microbioreactor system that fulfills this throughput-performance gap providing single-use, perfusion bioreactors with 2mL working volume that can replicate bench scale perfusion processes at industrially relevant cell densities.

Speakers:
Speaker
Kevin Lee
Merck
Co-founder of Erbi Biosystem
Speaker
Quang Long Pham, Ph.D.
Merck
Senior Scientist, Innovation-Cell Culture Media Development (ICMD), Bioprocessing Upstream R&D

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Achieving High Yields in Scalable Xeno-Free Culture Formats with Mesenchymal Stem Cell Medium

Subcategory: Upstream
Duration: 1 hour
Date: 22 July, 2021

In this webinar, you will:
  • Explore the current landscape and future trends of cell culture media for adult mesenchymal stem cells
  • Discover ways to derive MSCs from bone marrow in xeno-free conditions from static to microcarrier-based suspension culture platforms
  • Learn how Stemline® XF MSC Media provides robust performance and reduces scalability roadblocks
Detailed description:
Optimizing ex vivo cell expansion processes in preparation for clinical use is a critical step in cell therapy manufacturing. Given the curative and lifesaving impacts these therapies can have on patients, overcoming roadblocks with scalability and supply chain, using high quality raw materials are essential for therapeutic access.

The GMP-compliant Stemline® XF MSC Medium and cocktail promotes expansion of human mesenchymal stromal/stem cells (hMSCs) to high densities while maintaining cell identity and quality. This product was designed for derivation and expansion of MSCs using xeno-free conditions in planar and microcarrier-based culture platforms, easing the transfer between research, clinical, and manufacturing scale cultures.

Speakers:
Speaker
Kathleen Ongena, Ph.D.
Merck
Head of Customer Applications
Speaker
Mark Ventresco
Merck
Cell Therapy Product Manager

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Turnkey Solutions for Upstream Cell Culture Processes

Subcategory: Upstream
Duration: 1 hour
Date: 29 June, 2021

In this webinar, you will learn:
  • Common challenges faced in upstream development
  • Benefits of a one-step & neutral pH feed optimization strategy
  • Potential application of chemically defined hydrolysates
  • Benefits of supplement targeted at adjusting glycosylation attributes
Detailed description:
Chinese Hamster Ovary (CHO) cells are the preferred host for producing therapeutic proteins however, the development of recombinants is both resource and time-intensive. Feed combinations developed from EX-CELL® Advanced and Cellvento® technologies improve performance process development by not only decreasing the timeline of selecting high-producing clones but also simplifying the process by single feed at neutral pH reducing contamination risk and cell damage caused by alkaline feed.

Together with protein-quality supplements, these technologies reduce resources needed for process development thereby increasing the number of molecules that can be evaluated concurrently and enabling speed to market.

Speakers:
Speaker
Janice Tan
Merck
Head of Upstream MSAT, APAC excluding China
 
 
 
 

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Water Purification

Browse subcategory:

Subcategory: Laboratory Trends

How to Choose Best Adapted Water Quality for Food & Beverage

Duration: 1 hour
Subcategory: Laboratory Trends

What is the central reagent in the laboratory? Water, of course. Let us help your testing by providing tips for water quality to achieve reliable results.

Speaker:
Dr. Estelle Riché
Dr. Estelle Riché
Merck
Global Applications Specialist,
Milli-Q® Lab Water Solutions
 
 
 
 

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Lab and Instruments Monitoring

Duration: 1 hour
Subcategory: Laboratory Trends

In this webinar, Maryse Gauthey will describe how a connected water purification system can improve lab productivity and maximize uptime.

Abstract:
Lab and instrument monitoring can provide real-time insight into the status of your lab environment and equipment. Remote monitoring technology allows lab managers to observe the status of the lab environment and instruments and adjust as necessary. A wide range of lab instruments can be monitored with this technology including thermostats, freezers, analyzers, water purification systems, and many more. Join Lab Manager and MilliporeSigma as we explore the Milli-Q® Connect's remote monitoring capabilities on a range of water purification systems.

As an attendee you will learn more about:
  • How the Milli-Q® CLX 7000 Water Purification System and its monitoring capabilities can drive your lab efficiency
  • How connectivity can improve productivity and maximize uptime
  • How powerful data management facilitates data traceability, audits, and lab accreditation
Speaker:
Maryse Gauthey
Maryse Gauthey
Merck
Global Product Manager, Biomedical, Milli-Q® Lab Water Solutions
 
 
 
 

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The Importance of Health Authority Compliance within Regulated Industries

Duration: 1 hour
Subcategory: Laboratory Trends

This presentation will provide an overview of health authority expectations for those within pharmaceutical, medical device and combination product operations to include manufacturing, environmental monitoring and analytical supporting operations

The presentation will include an overview of verification and validation concepts as required by health authorities (U.S. FDA and EU) providing a general overview of approach strategies for validation. Current trend information resulting from recent health authority inspections and field actions will be presented as well as contributing root causes resulting in these observations. Primary focus will be referenced to the EU requirements (EudraLex, Volume 4, Good Manufacturing Practices), ICH Q10 (Pharmaceutical Quality System) and the U.S. FDA guidance for Aseptic Processing and Sterile Manufacturing.

Speaker:
Roland Emerson
Roland Emerson
Merck
Director, Deputy Head EQ-QA Corporate Quality
 
 
 
 

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Subcategory: Optimize Your Analytical Results

Are water contaminants impacting your experimental results? Selecting the best water quality for your science

Duration: 1 hour
Subcategory: Optimize Your Analytical Results

In this webinar, Estelle Riché, Global Application Specialist at Milli-Q® Lab Water Solutions Merck KGaA, Darmstadt, Germany, will discuss the importance of adapting the purity of the water you use in the lab to the type of experiment/s you are performing. She will provide concrete examples of the impact of water contaminants on your analyses, and explain how to obtain the best water quality for your work.

After watching this webinar you will understand:
  • The potential impact of water contaminants on everyday laboratory uses
  • How lab water is purified, and the different types of water availablethat can be obtained
  • How to select the best water purification solution to suit your needs
Speaker:
Dr. Estelle Riché
Dr. Estelle Riché
Merck
Global Applications Specialist,
Milli-Q® Lab Water Solutions
 
 
 
 

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A to Z of Water Systems: From Assured Quality to Zero Mercury

Duration: 1 hour
Subcategory: Optimize Your Analytical Results

Water is a ubiquitous and essential solvent in many laboratories. As modern analytical techniques are becoming increasingly sensitive, they require higher quality reagents, which includes ultrapure water. In addition to ensuring the consistent quality of water delivered to their labs, lab managers may need to consider other system features, including environmental impact, user-friendly design and data management solutions. In this webinar, Dr. Estelle Riche will demystify how laboratory water purification systems work, and explain how you can select the right solution to meet your laboratory's specific experimental needs.

At the end of this webinar, you will:
  • Understand the potential impact of different water contaminants on your laboratory's experimental results
  • Learn how water purification systems work to deliver water suited for even the most sensitive laboratory techniques
  • Receive advice on how to select an innovative water purification system that answers the specific needs of your laboratory
Speaker:
Dr. Estelle Riché
Dr. Estelle Riché
Merck
Global Applications Specialist,
Milli-Q® Lab Water Solutions
 
 
 
 

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Selecting the Right Water Quality for Modern Diagnostic Lab Applications

Duration: 1 hour
Subcategory: Optimize Your Analytical Results

Water is a ubiquitous and essential solvent in many laboratories. As modern analytical techniques are becoming increasingly sensitive, they require higher quality reagents, which includes ultrapure water. In addition to ensuring the consistent quality of water delivered to their labs, lab managers may need to consider other system features, including environmental impact, user-friendly design and data management solutions. In this webinar, Anastasia Khvataeva-Domanov will demystify how laboratory water purification systems work, and explain how you can select the right solution to meet your laboratory's specific experimental needs.

Abstract:
Today, activities of diagnostic laboratories are expanding far beyond classical areas such as immunochemistry, biochemistry, clinical microbiology, and histology to also address issues in toxicology or therapeutic drug monitoring. This growth is characterized by successful adaptation of various analytical platforms for analyses of hormones, drugs of abuse, biogenic amines, neonatal screening, etc. New techniques not only enable measurement of multiple complex analyses simultaneously with a very high level of sensitivity and robustness, but also establish new requirements for analyses with regard to process control, operator expertise, and reagent quality.

Speaker:
Anastasia Khvataeva-Domanov
Anastasia Khvataeva-Domanov
Merck
Application Support Scientist, Lab Water
 
 
 
 

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Pharma Labs: Getting the Most Out of Your Lab Water Solution

Duration: 1 hour
Subcategory: Optimize Your Analytical Results

This webinar may help scientists working in the pharmaceutical industry to critically evaluate their current lab water purification solution and discover the optimal solution for their particular needs.

Abstract:
High purity water is one of the main reagents in pharmaceutical laboratories and its quality plays a critical role in successful analyses. Any contamination present in water may interfere with measured analytes, contaminate the instrument, and finally compromise the analytical data — and also result in time wasted repeating analyses and cleaning/troubleshooting analytical instruments. To avoid these issues, the ultrapure water used in any pharmaceutical lab must be of high and constant quality with a minimum level of contaminants detrimental to analyses.

Thus, the practical aspects of ultrapure water quality will be highlighted during this session. In particular, specific characteristics that determine water of high quality, as well as aspects related to water handling in the lab will be discussed in detail with respect to pharmaceutical applications.

Pharmaceutical Quality Control laboratories must comply with complex and evolving regulatory guidelines. This webcast will provide the audience with everything they need to know in order to make sure that their lab water purification system is compliant with the guidelines issued by global regulatory bodies.

Speakers:
Anastasia Khvataeva-Domanov
Anastasia Khvataeva-Domanov
Merck
Application Support Scientist, Lab Water
Dr. Federico Dorati
Dr. Federico Dorati
Merck
Global Product Manager, Services Operation, Lab Water

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Subcategory: Sample Preparation

Selecting the Right Filter for Improved LC and LC-MS

Duration: Duration
Subcategory: Optimize Your Analytical Results

Selecting the right filter is critical for improved LC and LC-MS. Dr Vivek Joshi's webinar will be dedicated to describing the key components for success in LC, LC-MS and HPLC analyses.

Speaker:
Dr. Vivek Joshi
Dr. Vivek Joshi
Merck
Principal Research Scientist, Bioscience
 
 
 
 

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Subcategory: Tips and Tricks

Best Practices for Using a Water Purification System

Duration: Duration
Subcategory: Optimize Your Analytical Results

Water is so often used in the laboratory that we may take it for granted. In fact, it should be considered with the same care as other high-purity reagents. See why having a good-quality water purification system in your lab is only the first step.

Speaker:
Dr. Estelle Riché
Dr. Estelle Riché
Merck
Global Applications Specialist,
Milli-Q® Lab Water Solutions
 
 
 
 

Solutions for Mass Spectrometry - Tips, Tricks and Applications

Duration: 1 hour
Subcategory: Tips and Tricks

Dr. Stephan Altmaier will identify factors contributing to a potential LC-MS contamination, such as solvents or additive purity and will also describe the interactions of impurities with analytes (ion suppression, adduct formation) and their influence on system performance, sensitivity and limit of detection. This webinar will be of interest to anyone working with mass spectrometry who is interested in increasing system performance. The webinar will help you keep your MS clean and improve system performance, in terms of sensitivity and LOD.

Speaker:
Dr. Stephan Altmaier
Dr. Stephan Altmaier
Merck
Head of Application Laboratory HPLC-MS, Advanced Analytics
 
 
 
 

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Practical Tips to Get the Most from Your Lab's Water Purification System

Duration: 1 hour
Subcategory: Tips and Tricks

Water is the most commonly used solvent in laboratories, yet it is probably the least understood. The purity of laboratory water is an important factor for the optimization of experimental results and can boost productivity. In this webinar, we will share practical tips on how you can get the most out of your water purification system

At the end of this webinar, you will:
  • Learn how to use your water purification system in an optimal way.
  • Discover how to identify potential sources of water contamination, and understand how these contaminants may affect experimental results.
  • Understand how proper handling of ultrapure water will help boost your productivity.
Speaker:
Dr. Estelle Riché
Dr. Estelle Riché
Merck
Global Applications Specialist,
Milli-Q® Lab Water Solutions
 
 
 
 

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Subcategory: Water Purification Basics

Why Does a Simple Molecule Require Such High Quality?

Duration: Duration
Subcategory:Water Purification Basics

LC—MS instrumentation allows very sensitive analysis but requires high quality reagents, solvents, and ultrapure water. Join this webcast to learn about contaminants present in laboratory water and their effects on applications, as well as different modern water purification solutions that can be tailored for your specific experimental needs.

Speaker:
Anastasia Khvataeva-Domanov
Anastasia Khvataeva-Domanov
Merck
Application Support Scientist, Lab Water
 
 
 
 

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The Forgotten Variable: Laboratory Water Purity and its Impact on Your Experiments

Duration: Duration
Subcategory:Water Purification Basics

Join this exciting and interactive webinar about laboratory water. Learn about the potential impact of water purity on your experiments and how water is purified for use in the lab. You will also receive practical advice about how to obtain the best water quality from your purification system.

At the end of this webinar, you will have learned:
  • How analytical instruments (HPLC, LC-MS, etc.) and experimental results may be affected by contaminants in your lab water To identify these contaminants and understand how various water purification technologies can remove them from your lab water How to obtain the best water quality for your experiments
  • If you are a scientist using high purity water at any stage of your experiments, you should attend this webinar. This webinar is also valuable for your research teams, your lab manager, and anyone else using or maintaining lab water purification systems.
Speaker:
Dr. Estelle Riché
Dr. Estelle Riché
Merck
Global Applications Specialist,
Milli-Q® Lab Water Solutions
 
 
 
 

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