PT - JOURNAL ARTICLE AU - Robert D. Kiss TI - Practicing Safe Cell Culture: Applied Process Designs for Minimizing Virus Contamination Risk AID - 10.5731/pdajpst.2011.00852 DP - 2011 Nov 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 715--729 VI - 65 IP - 6 4099 - http://journal.pda.org/content/65/6/715.short 4100 - http://journal.pda.org/content/65/6/715.full SO - PDA J Pharm Sci Technol2011 Nov 01; 65 AB - CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1–3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) Genentech responded to a virus contamination in its biologics manufacturing facility by developing and implementing a series of barriers specifically designed to prevent recurrence of this significant and impactful event. The barriers included steps to inactivate or remove potential virus particles from the many raw materials used in cell culture processing. Additionally, analytical testing barriers provided protection of the downstream processing areas should a culture contamination occur, and robust virus clearance capability provided further assurance of virus safety should a low level contamination go undetected. This conference proceeding will review Genentech's approach, and lessons learned, in minimizing virus contamination risk in cell culture processes through multiple layers of targeted barriers designed to deliver biologics products with high success rates.