Vaccine potency assays

Abstract

Historically, vaccines have predominantly been manufactured through complex biological processes (growth in embryonic chicken eggs, bacterial fermentation, and mammalian cell culture) that can be challenging to control and reproduce. Although the introduction of Quality by Design principles is changing the the process is the product mindset, the development of appropriate release assays remains a critical element in ensuring the safety and efficacy of a vaccine throughout its shelf life. The development of relevant and robust potency assays requires careful consideration of the nature of the protective immune response to the targeted antigen as well as a detailed understanding of the structural features of the antigen that elicit the protective response.