Formulation and Characterization Strategies for Gene Therapies

This webcast features: Sarathi Vijay Boddapati, PhD, Associate Director, Formulation and Drug Product Development, Catalent Cell and Gene Therapy

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 & Gene Therapy is working towards an approach for gathering product knowledge and establishing formulation selection criteria using traditional/routine techniques that are historically used for biologics formulations as well as evaluating novel methodologies for gene therapy products.

Key Takeaways:

  • Considering formulation development for viral vectors
  • Applying knowledge gained from protein formulation development to viral vectors
  • Evaluating the appropriate tools to conduct formulation development

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