Application of PCR technology in vaccine product development

Abstract

The complex process of vaccine product development needs to be tightly controlled and closely monitored to ensure vaccine quality and consistency. Since its inception, PCR has been widely used in all stages of vaccine product development as a tool to assist in the evaluation of vaccine quality, safety and efficacy. In this review, the general principles of conventional and real-time quantitative PCR (Q-PCR) technology and its application in vaccine product development for quantitation of vaccine dose (genome quantitation assay), infectivity (Q-PCR-based potency assay), process residuals, stability, adventitious agents, safety assessment and clinical studies are described. The future outlook and the advantages and disadvantages of this technology are also discussed.

Keywords::

• adventitious agents
• biodistribution
• clinical assays
• DNA
• host cell
• infectivity
• integration
• mass
• PCR
• potency
• residuals
• vaccine

Acknowledgements

The authors acknowledge the encouragement and support provided by their management, intense scientific and technical discussions with colleagues, and experimental work in the laboratory that led to the fruition of some work described here. The authors would particularly like to thank Jose Lebron, Katey Owen, Frank Taddeo, Stephen Pacchione, Philip Troilo and Szi-Fei Feng for critical review of this manuscript.

Financial disclosure

All authors are employed by Merck & Co., Inc. They all own Merck stock and stock options.