As the pipeline of viral vector-based therapies continues to reach later stage studies, a standardized manufacturing process is necessary for chemistry, manufacturing and control (CMC) requirements from regulatory agencies and to meet the accelerated timelines for first-in-human studies of advanced therapeutics. Catalent’s UpTempo Virtuoso™ AAV platform process is a scalable, CGMP-ready process for viral vector manufacturing that can reduce the current 18-20-month development timeline for drug product in half.
The platform process was developed for standard AAV serotypes, including 1, 2, 5, 6, 8, and 9. With the completion of reference standard and toxicology batches, the upstream and downstream processes are locked for CGMP production at up to 400L scale. Overall, starting with CGMP grade plasmid DNA and a master cell bank, with the UpTempo Virtuoso™ platform, the development and manufacturing process will yield drug product in 9 months. Catalent’s platform process partners will also have access to our integrated supply chain of plasmid DNA, potentially further streamlining their timeline.