Wendy Saffell-Clemmer

The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.

The author discusses the impact of prefilled syringe product contact materials and the filling and stoppering process on protein aggregates.

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.