The suspension-based platform includes standard protocols for cell culture, transfection, and downstream purification, as well as a standardised bill of materials
Global CDMO Catalent has introduced its UpTempo Virtuoso platform process for the development and manufacturing of adeno-associated viral (AAV) vectors. The platform is designed to standardise and streamline several of the steps in AAV manufacturing to reduce the timeline from gene to clinic.
The suspension-based platform includes standard protocols for cell culture, transfection, and downstream purification, as well as a standardised bill of materials to simplify the critical supply chain and material qualification. The platform is designed to provide a CGMP-ready, high-titer process capable of yielding drug product for evaluation in nine months. Customers using this process will also have access to the CDMO’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 specialised 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, PhD, 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 optimised and standardised CGMP manufacturing process is designed to meet robust CMC submissions for AAV gene therapy products, while providing customers with the advantage of shortened timelines.”
The company’s network of pDNA and viral vector clinical and commercial facilities offer horizontally integrated solutions to support advanced therapy programmes.