CONTINUOUS IN-LINE VIRUS INACTIVATION FOR NEXT GENERATION BIOPROCESSING

摘要

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.