The discussion on facility risk mitigation was included for the first time at the 2017 Viral
Clearance Symposium. A few topics were discussed in this session, including …

Appropriate segregation within manufacturing facilities is required by regulators and utilized
by manufacturers to ensure that the final product has not been contaminated with (a) …

Some members of MIT's Consortium on Adventitious Agent Contamination in
Biomanufacturing (CAACB) previously published content on the “Quality Risk Management …

Viral contamination is a potential risk of using biotechnology products derived from
mammalian cell lines. Therefore, to provide assurance of the safety of these products …

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in
Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December …

This report provides a high-level summary of the key outcomes and gaps based on the
research presented at the 2019 Viral Clearance Symposium and identifies new areas for …

Virus contamination events in cell culture-based biotechnology processes have occurred
and have had a dramatic impact on the supply of life-saving drugs, and thus on the …

This article introduces the presentations from the 2019 Viral Clearance Symposium, which
was held in Claremont, California. The Viral Clearance Symposium contained regulatory …

The article provides information on viral safety challenges in bioprocessing at the chemical
industries. Topics include how the biopharmaceutical manufacturing industry keeps viruses …

Adventitious contamination of a manufacturing process is a major concern for
biopharmaceutical manufacturers. This session focused on rapid detection methods for …