PT  - JOURNAL ARTICLE
AU  - Khan, Arifa S.
TI  - Current Testing Methods and Challenges for Detection of Adventitious Viruses
AID  - 10.5731/pdajpst.2011.00831
DP  - 2011 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 627--633
VI  - 65
IP  - 6
4099  - http://journal.pda.org/content/65/6/627.short
4100  - http://journal.pda.org/content/65/6/627.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) Adventitious viruses are a major safety concern in biological products. This paper discusses various sources of virus contamination and approaches to develop a comprehensive detection and mitigation strategy for product safety. Additionally, general safety concerns related to adventitious agents in biologics and current testing recommendations by the Center for Biologics Evaluation and Research for demonstrating the absence of adventitious agents in viral vaccines will be presented. The limitations of the conventional assays and the need for and consideration of new technologies for broad detection of novel agents will also be discussed.