Scientific Publications by FDA Staff

PDA J Pharm Sci Technol 2011 Nov 1;65(6):627-33

Current testing methods and challenges for detection of adventitious viruses.

Khan AS

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.