Analytical considerations to support expeditious formulation development of vaccines

Vaccine potency assays pose a unique challenge due to the inherent structural complexity, multivalent composition, long shelf-life and global distribution of vaccines [1]. Potency assays are required for measuring functional integrity of antigens and confirming their immunocompetence during lot release and stability over real-time (2–8°C storage) and under accelerated conditions (e.g., 37°C storage) [2]. A variety of potency assays have been employed for quality control (QC) testing of vaccines, ranging from in vivo animal challenge assays, in vitro cell-based infectivity assays, ELISA, HPLC assays, etc.