Abstract
In session 2 of the Viral Clearance symposium 2019 new outcomes of viral clearance performance of polishing chromatography and depth filters utilized in the purification processes of biotechnologically produced recombinant proteins such as monoclonal antibodies were presented. It was shown that flow through both multimodal anion exchange and anion exchange chromatography are effective tools for removal of retroviruses and, under defined conditions, also for parvoviruses. Cation exchange chromatography, when operated in bind/elute mode, hydrophobic interaction chromatography and depth filtration can also be potent for virus removal, but is less robust for parvoviruses. Despite these data provide further understanding on virus removal mechanisms by chromatography and depth filtration operations, more investigation is required for a clear understanding on the molecular mechanisms of virus removal and the relevance of different molecule′s interactions including resin, virus, and product.
- Received August 10, 2021.
- Accepted November 24, 2021.
- Copyright © 2021, Parenteral Drug Association
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