DR. ANUSHREE HERWADKAR

Formulation & Characterization Strategies for Gene Therapies

Formulation studies for Gene therapy products are currently limited in scope and revolve around gathering stability data at frozen storage conditions. A systematic approach towards understanding degradation mechanisms followed by buffer and excipient selection is required. Catalent Cell and Gene therapy is working towards an approach for gathering product knowledge and establish formulation selection criteria using traditional/routine techniques, historically used for biologics formulations, as well as evaluating novel methodologies for Gene therapy products.