Proceedings of the 2019 Viral Clearance Symposium, Session 7: Cell Banks and U.S. Pharmacopeia

Abstract

Adventitious contamination of a manufacturing process is a major concern for biopharmaceutical manufacturers. This session focused on rapid detection methods for adventitious agents and mitigation methods for upstream media and feeds. In the first session, it was shown that next-generation sequencing (NGS) can be a good rapid alternative to existing methods used to detect adventitious virus contamination. The second session showed that upstream virus barrier filters can robustly remove virus from media and feeds and could be a good alternative to high-temperature short time (HTST) aimed at facility contamination risk mitigation. In the third session, testing for Mycobacterium species was requested by the Chinese health authority for cell banks. In this case, the risk of mycobacterial contamination was minimal for well-characterized cell banks, and robust downstream processes are in place to remove any potential adventitious contaminants such as viruses and bacteria; therefore, it was not needed. In the final session, a review of rapid testing methods for viral detection was discussed as well as the possibility of using these technologies to replace existing methods.