In Session 2 of the 2019 Viral Clearance Symposium, 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 are less robust for parvoviruses. Despite these data provide further understanding of virus removal mechanisms by chromatography and depth filtration operations, more investigation is required for a clear understanding of the molecular mechanisms of virus removal and the relevance of different moleculés interactions including resin, virus, and product.
Keywords: Anion-exchange chromatography; Depth filtration; Hydrophobic interaction chromatography; Multimodal anion exchange chromatography; Polishing chromatography; Viral clearance.
© PDA, Inc. 2022.