A rational, systematic approach for the development of vaccine formulations.

With the continuous emergence of new infectious diseases and new strains of current diseases, such as the novel H1N1 influenza in 2009, in combination with expanding competition in the vaccine marketplace, the pressure to develop vaccine formulations right the first time is increasing. As vaccines are complex, costly, and have high risk associated with their development, it is necessary to maximize the potential for development of a successful formulation quickly. To accomplish this goal, the historical empirical approach to formulation development needs to be updated with a rational, systematic approach allowing for more rapid development of safe, efficacious, and stable vaccine formulations. The main components to this approach are biophysical characterization of the antigen, evaluation of stabilizers, investigation of antigen interactions with adjuvants, evaluation of product contact materials, and monitoring stability both in real time and under accelerated conditions. An overview of investigations performed for each of these components of formulation development is discussed. The information gained in these studies is valuable in forming the base of knowledge for the design of a robust formulation. With the use of continually advancing technology in combination with maintaining a rational, systematic approach to formulation development, there is a great increase in the probability of successfully developing a safe, effective, and stable vaccine formulation.