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Detect Viral Contamination


Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/detect-lab-image.jpgGlobal regulatory guidance documents and reflection papers outline biosafety testing strategies and recommendations for viral testing; their expectation is that no adventitious virus should be detected in production processes. Traditional tests for adventitious viruses offer opportunities for broad detection of diverse viruses however, these are time consuming tests and have limitations in terms of sensitivity and identification of specific contaminants.

Molecular testing technologies such as Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) complement traditional cell based methods, opening doors for more rapid, sensitive detection of viral contaminants.

Browse this page and learn more on viral detection challenges and innovation.

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Watch our video to learn more about viral detection
1. Confirm that adventitious agents are not present in cell banks
Cell line characterization is required by the regulatory bodies to confirm the species origin and history of the cell line; and characterize and test its identity, stability, and purity.

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This webinar describes a number of topics in the areas of cell line characterization and bulk harvest testing for contaminants where new technical innovations are occurring. The regulatory response to these developments is discussed.
 

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Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: GEN roundup on cell-line authentication
 
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Viral risk mitigation: A global regulatory perspective – Special report, BPI, 2018


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Cell line characterization

Cell Line Characterization is required by the regulatory bodies to confirm the species origin and history of the cell line; and characterize and test the identity, stability and purity.




2. Confirm that adventitious agents are not present in raw materials and bulks
Variability is inherently introduced by bioprocessing raw materials. A detailed initiative to fully characterize raw materials using orthogonal techniques can provide assurance that the raw materials are fit for purpose.

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In this webinar you will learn:
  • Approaches to develop a risk mitigation program
  • Methods of characterizing biopharma raw materials
  • Variability in biopharma raw materials


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Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Clearing viral concerns in animal-derived biomaterials
 

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Assuring equivalency of alternative lot-release test methods


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Raw material testing

Our services are aimed at ensuring the quality and purity of raw materials used in the production of biologics

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Bulk lot release testing

We offer a comprehensive range of services and assays aimed at ensuring the quality and purity of unprocessed and purified bulk harvest materials used in the production of biologicals for the pharmaceutical and biotech industries.


3. Accelerate biosafety testing of biological therapies
Increased understanding of viral contamination risks in biologics production, and the need for manufacturers to have rapid results, has necessitated development of fast, sensitive tests for detecting viral contamination.  

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This webinar explores how rapid methodologies are being used to accelerate biosafety testing and enhance quality by reducing testing complexity. Existing technologies as well as emerging trends are discussed, along with the implications these may have on the regulatory landscape.
 

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Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Sponsored tutorial, GEN: Utility of Next-Generation Sequencing (NGS) for Biosafety Assessment of Biological Products


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Next Generation Sequencing

Our expertise in NGS-based biosafety testing services allows us to provide complete genomic analysis solutions to our clients, from sample preparation and library generation through sequencing and data mining using state of the art computational and bioinformatics platforms, tools and methodologies.


4. Detect emerging viruses in raw materials
Viral contamination is a constant challenge to all biopharmaceutical production processes. Emerging viruses are of particular concern and need to be characterized to understand the potential threat to your process. Understanding the susceptibility of your raw materials to these viral contaminants, and the capability of classical assays to detect them, will affect your viral safety strategy.  

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Using Zika, Schmallenberg and Hepatitis E viruses as examples, watch our webinar to learn how to evaluate the risk of emerging viruses in raw materials and integrate appropriate testing into a holistic viral safety strategy.
 

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Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Schmallenberg virus, an emerging viral pathogen of cattle and sheep and a potential contaminant of raw materials, is detectable by classical in-vitro adventitious virus assays
 

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/Virus-Safety-Assurance/icon-note-rp.svg Article: Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals


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Adventitious Agents / Virology Testing

We perform in vitro assays designed to detect adventitious viruses in cell banks, virus seed stock, raw materials and final products.