ABSTRACT
The development of effective vaccines against several deadly infectious diseases has contributed to increased life expectancy globally. This chapter discusses various vaccine formulations and the requirement for improved characterization of vaccine antigens, adjuvants, and the final antigen-adjuvant drug products. It highlights the importance of early understanding of vaccine antigens, adjuvants, and antigen–adjuvant interactions in the vaccine formulation. The chapter also discusses the process and importance of formulation and characterization of physicochemical and functional properties of vaccines. Regardless of its therapeutic or prophylactic nature, formulating a vaccine or vaccine combination to maintain its functionality and physicochemical stability is an integral part of the product development process. After confirming a well-controlled process through the validation of multiple lots, one should maintain the formulation process and product attributes in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change.
