Title

Continuous in-line virus inactivation for next generation bioprocessing

Conference Dates

September 17-21, 2017

Abstract

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. A bottleneck in connected processing is the viral inactivation step, which is typically accomplished by holding the Protein A elution material in a large vessel for a fixed period of time. There are multiple factors to consider when translating this inherently batch operation into a continuous mode. In this presentation, we will describe our efforts to develop a comprehensive understanding of virus inactivation kinetics and the impact of buffer/mAb composition on the virus inactivation process. Based on this knowledge, a flow-through system can be designed to achieve the desired virus clearance capabilities. We will also describe how such in-line virus inactivation processes may lead to shorter processing times, reduced facility footprint, and simpler integration with adjacent processing operations. Technologies such as in-line virus inactivation are expected to play an important role in the next generation mAb processing toolbox.

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