Blood Plasma Fractionation

 
 
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Your Gateway to Fractionation Solutions


Plasma fractionators play a critical role in the treatment of rare life-threatening conditions. Consistent, reliable performance is key to plasma fractionation – and that means choosing a partner who understands your challenges of process development, quality purification, process economics, and regulatory requirements.

Let us show you how we can help you better serve your patients globally in these areas of your business.

Process Development  | Quality Plasma Purification | Process Economics | Regulatory

Process Development

Whether it’s increasing productivity, improving your process economics, expanding your plant capacity or developing, or optimizing and transferring your processes globally, we can help.

Provantage® Process Services
From Process Development to Facility Design and Construction, we have options that will streamline your process, reduce costs, and mitigate risk, anywhere in the world.


Learn More About Provantage® Process ServicesMerck:/Freestyle/PS-Process-Solutions/Learning-Centers/plasma/people-desk-400px.jpg 



Quality Plasma Purification

According to global regulatory standards, plasma therapeutics must have a certain product quality and impurity profile. Let us help you optimize your process with our portfolio of industry-leading technologies.

Sterile Filtration
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Learn about our capabilities in the areas of plasma fractionation sterility and product quality, and security of supply, and then find the best filter for your plasma fractionation process.

On-Demand Webinars:
Sterile Filtration Validation Best Practices
Designing an Economic and Efficient Buffer Operation

Learn More About Sterile Filtration
Single-Use Capabilities
Strategically leveraging single-use technologies in key areas of the plasma production process provides significant advantages including a decreased risk of contamination, reduced cleaning validation downtime and minimized operator exposure.

Learn More About Our Single-Use Technologies
Purification
Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/plasma/purification.jpgPlasma chromatography is the answer to your high purity therapeutic needs. We offer a complete portfolio of resins, buffers, Cleaning in Place (CIP) solutions and hardware.

Ion Exchange (IEX) Chromatography is the most widely used method to produce pure protein products. Size Exclusion (SEC) Chromatography is the method of choice for polishing plasma-derived therapeutics.

Chromatography Volume and Flow Rate Calculator

Explore our portfolio of industry-leading ultrafiltration devices, including our newest ultrafiltration technology that is optimized to overcome high viscosity challenges under normal processing limits and conditions.

Join our online forums to discuss various topics of interest for purification:
Chromatography Community
TFF Experts Community

On-Demand Webinars:
Overcoming High Concentration Challenges in IgG Purification
High Viscosity Ultrafiltration Formulation for Plasma IgG and mAbs

Virus Safety
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Protect your process from start to finish – download this brochure to better understand how can you assure viral safety of your drug product.

Learn more about the critical steps of virus control:

On-Demand Webinar:
Solvent Detergent Viral Inactivation using Single-use Technology in Blood Fractionation Processes

Learn More About Virus Safety
Excipients for Blood Plasma Formulation
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To solve the challenge of stability requirements, we offer a wide range of pharmaceutical excipients comprising important functionalities, allowing you to formulate and manufacture stable plasma products.

Quickly sort our portfolio by dosage form, application, or other parameters with this formulation finder.

On-Demand Webinar:
Excipient GMP: The Industry Journey from Guides to Standards

Learn More About Excipients
for Blood Plasma Formulation


Process Economics

Merck:/Freestyle/PS-Process-Solutions/Learning-Centers/plasma/boxes.jpgPlasma fractionation is a cost competitive market. It is important to have a robust, efficient, and cost effective process. Reliable vendor partnerships and hybrid facilities with single-use technologies can help you keep your facilities running efficiently and economically.

On-Demand Webinars
Securing Your Supply Chain for Filters – Learn how we define equivalence and minimize the impact of change on your process.

Implementing Single-use Technologies – Plasma Case Study – This presentation discusses the implementation of single-use technologies focusing on operational flexibility, overall process timing, and economics.



Regulatory

New Emprove® Program

Click here to watch from tablet or mobile device. 

With the industry facing ever increasing regulations for risk assessment, we’ve broadened the scope of our Emprove portfolio and dossier structure to help you meet the latest regulatory requirements and speed your way through the regulatory maze.

Learn More About Our New Emprove® Program
BioReliance Testing Services
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Testing animal derived raw materials used in manufacturing is critical. Specifically, our bioburden testing service can provide an accurate basis for calculating effective sterilization doses for a given therapeutic.

Manufacturers of biologics are also required to assess the quality and purity to ensure products are safe for use in humans. BioReliance offers the following Analytical Services:


Learn More About BioReliance Testing Services

Regulatory Authority Guidance
Visit the following websites for the latest information on plasma fractionation guidelines:


On-Demand Webinars:
Risk Assessment: Challenges & Best Practices – Gain insight into the EU Commission’s risk assessment approach to excipient quality and the challenges that can be overcome. You will also learn practical considerations and best practices to support risk assessment activities.

Risk Based Assessment of Sterilizing Grade Filters – Gain insight into current and upcoming industry and regulatory requirements for filters, such as more detailed compatibility and extractables data.