RT Journal Article
SR Electronic
T1 Massively Parallel Sequencing for the Detection of Adventitious Viruses
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 663
OP 667
DO 10.5731/pdajpst.2011.00836
VO 65
IS 6
A1 J. L. Kolman
YR 2011
UL http://journal.pda.org/content/65/6/663.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) The rate at which unknown adventitious agents are being discovered is accelerating. The ability to mitigate this risk begins with detection. Several molecular technologies for the detection of adventitious agent genomic signatures are reviewed here. Massively parallel sequencing (MP-Seq) is distinguished by its breadth of coverage. Supported by trained virologists and as part of a quality system, MP-Seq can be an early detection method for safe production of biologics.