Proceedings of the 2019 Viral Clearance Symposium, Session 3: Continuous Processing

Scott Lute; Rachel Specht

doi:10.5731/pdajpst.2021.012679

Abstract

Successful implementation of continuous processing requires an understanding of how to incorporate viral testing and clearance/inactivation into the process via representative small-scale models. Following the lead of the 2017 Viral Clearance Symposium, a session was devoted to understanding the impact of continuous process conditions on viral safety, how to design process for continuous viral inactivation/removal, and how to leverage existing batch data for a continuous process. In this session, there was a presentation investigating the impact of extended continuous cell culture on the production of endogenous retroviral-like particles, two presentations on the robustness of multicolumn capture chromatography and continuous viral filtration for clearance of viral particles, two talks on leveraging well-characterized batch processing data and scientific knowledge to demonstrate viral clearance capabilities of continuous processing, and finally two presentations related to process designs for continuous viral inactivation. Overall, this session provided additional scientific knowledge to support viral clearance strategies when implementing a continuous manufacturing process.

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