PT  - JOURNAL ARTICLE
AU  - McClenahan, Shasta
AU  - Uhlenhaut, Christine
AU  - Krause, Philip R.
TI  - Regulatory Approaches for Control of Viral Contamination of Vaccines
AID  - 10.5731/pdajpst.2011.00819
DP  - 2011 Nov 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 557--562
VI  - 65
IP  - 6
4099  - http://journal.pda.org/content/65/6/557.short
4100  - http://journal.pda.org/content/65/6/557.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) Improved assurance that vaccines do not contain harmful adventitious agents is expected to enhance public confidence and promote vaccine benefit. The recent discovery of porcine circovirus 1 in some rotavirus vaccines using massively parallel sequencing suggests that newer technologies could be employed both to identify potential adventitious viral agents and to provide increased assurance that such agents are absent. This article includes a discussion of the new virus detection methods and approaches that could be used to facilitate their use in a regulatory setting.