title: Risk mitigation strategies for viral contamination of biotechnology products: consideration of best practices.
abstract: 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) Viral contamination of biotech product facilities is a potentially devastating manufacturing risk and, unfortunately, is more common than is generally reported or previously appreciated. Although viral contaminants of biotech products are thought to originate principally from biological raw materials, all potential process risks merit evaluation. Limitations to existing methods for virus detection are becoming evident as emerging viruses have contaminated facilities and disrupted supplies of critical products. New technologies, such as broad-based polymerase chain reaction screens for multiple virus types, are increasingly becoming available to detect adventitious viral contamination and thus, mitigate risks to biotech products and processes. Further, the industry embrace of quality risk management that promotes improvements in testing stratagems, enhanced viral inactivation methods for raw materials, implementation and standardization of robust viral clearance procedures, and efforts to learn from both epidemiologic screening of raw material sources and from the experience of other manufacturers with regard to this problem will serve to enhance the safety of biotech products available to patients. Based on this evolving landscape, we propose a set of principles for manufacturers of biotech products: Pillars of Risk Mitigation for Viral Contamination of Biotech Products.
authors.affiliation: Division of Therapeutic Proteins, Office of Biotechnology Products, CDER, FDA.
authors.forename: Amy S
authors.initials: AS
authors.lastname: Rosenberg
authors.forename: Barry
authors.initials: B
authors.lastname: Cherney
authors.forename: Kurt
authors.initials: K
authors.lastname: Brorson
authors.forename: Kathleen
authors.initials: K
authors.lastname: Clouse
authors.forename: Steven
authors.initials: S
authors.lastname: Kozlowski
authors.forename: Patricia
authors.initials: P
authors.lastname: Hughes
authors.forename: Rick
authors.initials: R
authors.lastname: Friedman
mesh_terms: D001688:Biological Products; D001709:Biotechnology; D004340:Drug Contamination / Q000517:prevention & control; D006801:Humans; D016133:Polymerase Chain Reaction; D012306:Risk; D012308:Risk Management; D014780:Viruses
chemical_list: D001688:Biological Products