- End-to-End Services: From molecule to commercial production
- Scale Up & Tech Transfer Services
- Process Development Services
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|Process Development|||||Quality Plasma Purification|||||Process Economics|||||Regulatory|
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.
Sterile Filtration Validation Best Practices
Designing an Economic and Efficient Buffer Operation
Learn More About Sterile Filtration
Learn More About Our Single-Use Technologies
Plasma 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:
TFF Experts Community
Overcoming High Concentration Challenges in IgG Purification
High Viscosity Ultrafiltration Formulation for Plasma IgG and mAbs
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:
Solvent Detergent Viral Inactivation using Single-use Technology in Blood Fractionation Processes
Learn More About Virus Safety
Excipients for Blood Plasma Formulation
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.
Excipient GMP: The Industry Journey from Guides to Standards
Learn More About Excipients
for Blood Plasma Formulation
New Emprove® Program
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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
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:
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.