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.
- Learn more about optimizing and sizing AEX membrane adsorbers for virus clearance and the effects of buffer conditions on MVM retention.
- Gain insights into the importance of accurate loading capacity and learn how to determine it correctly.
- Understand the relevance of virus spike purity during virus clearance studies. Data will be shown comparing the retention results of purified virus preparations with non-purified virus preparations.
Watch the recorded webcast now.