The shift in industry toward connected and continuous monoclonal antibody (mAb) processing has necessitated the development of novel approaches to improve or replace traditional unit operations that rely on hold tanks or operate in bind-elute mode.  One such operation is virus inactivation with low pH, a critical virus reduction step in mAb downstream processing.  Traditional low pH inactivation operations involve one or more large holding tanks in which product is maintained at a target low pH level for a specific period of time, typically 30-60 minutes.  Translating this batch operation to a flow-through continuous process requires careful control of multiple factors to assure effective virus inactivation.<br/> <br/>In this presentation, we describe the impact of buffer/mAb composition on the kinetics of virus inactivation.  We address incubation chamber design which has implications for system size, processing times, and safety factor.  Data demonstrating equivalency between batch and in-line systems is also presented.  In-line technology that replaces batch operations and enables effective virus inactivation is expected to play an important role in the development of next generation mAb processing operations.

Continuous in-line virus inactivation for next generation bioprocessing

255th National Meeting (2018)

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