Catalent, the global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today introduced its new, UpTempo Virtuoso™ platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors. The UpTempo Virtuoso platform standardizes and streamlines many time-consuming steps in AAV manufacturing to significantly reduce the timeline from gene to clinic and enable rapid first-in-human clinical evaluation.

The suspension-based UpTempo Virtuoso platform includes optimized standard protocols for cell culture, transfection, and downstream purification, as well as a standardized bill of materials to simplify the critical supply chain and material qualification. The new platform is designed to provide a CGMP-ready, high-titer process that is capable of yielding drug product for clinical evaluation in nine months, potentially reducing the conventional development pathway by half and affording more predictable outcomes. Customers using this new process will also have access to Catalent’s integrated supply chain of plasmid DNA (pDNA), offering further potential to reduce development timelines.

“As one of the first CDMOs to successfully develop a suspension-based transient transfection process, and our deep and specialized viral expertise and broad experience across more than 70 viral vector programs, we have built this new process with the goal of providing our customers with a reliable, reproducible, and scalable path to clinic,” said Manja Boerman, Ph.D., President, Cell & Gene Therapy at Catalent. “As the gene therapy pipeline expands to a broader disease portfolio, and in anticipation of rising regulatory requirements, our optimized and standardized CGMP manufacturing process is designed to meet robust CMC submissions for AAV gene therapy products, while providing customers with the advantage of shortened timelines.”

Catalent’s global network of pDNA and viral vector clinical and commercial facilities offer horizontally integrated solutions to support advanced therapy programs from gene to clinic. Its Maryland-based network includes viral vector programs in Baltimore and Gaithersburg, and commercial-scale manufacturing at its FDA- and EMA-approved facility in Harmans/BWI. Production of pDNA from research grade through to CGMP quality material is carried out at sites in Rockville, Maryland, and Catalent’s European Center of Excellence in Gosselies, Belgium.