Platform Processes Accelerating AAV Vector Production from Gene to Clinic

The cell and gene therapy market continues to grow rapidly with new molecules entering clinical trials and many reaching late-stage clinical studies for life-changing therapies for previously untreatable diseases including monogenetic disorders, cancer, and infectious diseases.  Adeno-associated viral (AAV) vectors are the primary vector used for the production of viral vector-based gene therapies.  As demand for AAV vector manufacturing has grown, so too has the demand for plasmid DNA, a critical component to many advanced therapeutics.  Some of the challenges facing cell and gene therapy manufacturing are scalability, the lack of advanced platform processes, and supply chain bottlenecks.  During this talk, Catalent’s platform manufacturing processes for plasmid DNA and AAV vectors will be presented, including how they can address these challenges, support early activities, and facilitate the transition towards GMP production for clinical and commercial supply.

• The features of plasmid and AAV platform processes


• The advantages of securing plasmid bioproduction services that are fully integrated within viral vector and cell therapy manufacturing capabilities

How a platform manufacturing process can accelerate advanced therapies from gene to clinic