Scientific Publications by FDA Staff

PDA J Pharm Sci Technol 2011 Nov 1;65(6):557-62

Regulatory approaches for control of viral contamination of vaccines.

McClenahan S, Uhlenhaut C, Krause PR

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.