RT Journal Article
SR Electronic
T1 Current Testing Methods and Challenges for Detection of Adventitious Viruses
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 627
OP 633
DO 10.5731/pdajpst.2011.00831
VO 65
IS 6
A1 Arifa S. Khan
YR 2011
UL http://journal.pda.org/content/65/6/627.abstract
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.