Formulation and Development of Recombinant Protein Vaccines

Abstract

Recombinant protein vaccines are fast becoming the focus of the vaccine industry due to their increased safety. Here we examine the development of several recombinant protein vaccines and the challenges involved. Once an antigen is identified, and a process to recombinantly produce the protein established, the first step is to perform a biophysical characterization of the macromolecule. The protein is stressed with respect to variables such as temperature and pH and monitored for perturbations in physical structure indicating potential sources of instability. In the second step, we examine aspects of formulation such as excipient screening and adjuvant adsorption which may enhance the antigen immunogenicity and stability. The third step involves evaluating the working formulation in an animal model to establish dose dependency and the effect of the adjuvant. Finally, accelerated and real-time stability studies are being completed, and the formulations adjusted accordingly.