Development, Validation, and Implementation of GMP Release Potency Assays for Vaccines

The function of vaccines is to deliver antigens in order to induce an immune response and immune memory. Vaccines can be categorized according to either the method of antigen presentation or their intended use. Most vaccines are preventative, which induce long-term immune memory that can protect the host in the future from infection or lessen the severity of disease. Vaccines generate immunity by two main responses: humoral immunity or cellular response immunity. One of the biggest challenges facing most vaccine manufacturers is the actual development of a biological assay for the estimation of potency of the vaccine.

This presentation will provide some guidance and information on the development, validation, and ultimately, the implementation of GMP batch release potency assays for vaccines.


  • Carmen Sweeney, PhD, MSc, Technical Manager, Charles River