Best Practices for Ensuring High Virus Clearance When Using Anion Exchange Membrane Adsorbers

This webcast features: Sherri Dolan, Global Technology Consultant, Separations Marketing Group, Sartorius Stedim Biotech

The risk of viral contamination is a concern for all biopharmaceuticals and vaccines derived from cell lines and can have serious implications. Contamination events can cost millions of dollars in investigation, clean-up, corrective action, and manufacturing plant downtime. Most importantly, such events pose a safety risk to the patient. To ensure the safety of biological products, regulatory agencies require manufacturing processes to have a validated current good manufacturing practice (CGMP) downstream purification process that can remove and/or inactivate a wide variety of viruses. The validated process should conform to an orthogonal approach (utilizing different methods), which often includes anion-exchange chromatography (AEX).

The purpose of this webinar is to guide users on the best practices when optimizing and sizing AEX membrane adsorbers for virus clearance. Minute virus of mice (MVM) is considered to be the most difficult virus to remove based on its small size and pI that is often close to that of a targeted product. The data presented will show the effect of different process conditions, such as buffer conductivity, on MVM clearance. In addition, accurate loading capacity can be critical to successfully utilizing AEX membrane adsorbers. We will discuss how to determine the loading capacity correctly and will show data to illustrate the importance of using purified virus preparations when validating membrane adsorbers.

Three Takeaways:

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