Integrated Design and Development of Recombinant Vaccines

Translational development of new concepts for vaccines from discovery to the clinic has required unique processes tailored to the characteristics of each immunogen and final vaccine product.  For recombinant vaccines, each immunogen may have its own properties and specifications that confer immunogenicity, and development usually begins with optimizing production of a selected sequence, followed by serial development of steps for recovery of the antigen.  With these materials in hand, product development follows formulation development and stability studies.  This approach to process development is linear, with limited feedback into prior stages including discovery and early evaluation of candidate vaccines.  Iterative learning from one vaccine to another can be also limited and process development often starts new each time.  This talk will present an integrated platform-like approach to recombinant vaccine development that incorporates an iterative design process emphasizing molecular design of antigens, strain engineering and integrated straight-through purification for recombinant proteins with examples for rotavirus and SARS-CoV-2 vaccine candidates.