Case Histories

A Rational, Systematic Approach for the Development of Vaccine Formulations : To accomplish the goal to maximize the potential for development of a successful formulation quickly, 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. The information gained in these studies is valuable in forming the base of knowledge for the design of a robust formulation.

This is the use of continually advancing technology in combination with maintaining a rational, systematic approach to formulation development that VaxForm LLC brings you to increase your success in developing a safe, effective, and stable vaccine formulation.

  • Prior to optimization the liquid vaccine was out of spec after only 1 month.
  • A stable formulation was developed that met the stability goals of the project: Optimized formulation allowed for antigen sparing by reducing the necessity for a formulation over age.
  • A formulation with enhanced stability was required for international markets.
  • A lyophilized presentation was developed: Stability of the vaccine at 45° C was more than double the liquid formulation.