Viral clearance studies are part of a multifaceted approach to ensure the safety of biopharmaceutical products. In order to prevent costly changes to a manufacturing process, it is important to assess each unit operation for its efficiency on the removal or inactivation of adventitious agents early on during downstream process development. We utilized a DoE approach to investigate the effect of buffer pH, sodium chloride concentration, residence time, and load level of feedstream on the removal of two viruses, Minute Virus of Mice (MVM) and Xenotropic Murine Leukemia Virus (XMuLV), as well as the removal of other product- or process-related, impurities by the mixed-mode chromatography media Nuvia aPrime 4A. Results from this study have offered insights on the interactions between the resin and virus particles, as well as the design space for the removal of MVM and XMuLV.

Evaluation of viral clearance using a mixed-mode chromatography resin

ACS Fall 2021

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