Catalent Expands UpTempo AAV Platform to Accelerate Development of Gene Therapies

Catalent recently announced the expansion of its UpTempo platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors. The platform now includes an in-house, clonal HEK293 cell line, and off-the-shelf plasmids to support a robust supply chain for the development and manufacture of gene therapies, and the reduction of timelines to first-in-human clinical evaluation.

Catalent launched its UpTempo platform in 2022, to standardize protocols for cell culture, transfection, and downstream purification, as well as implementing a single, uniform bill of materials to simplify the critical supply chain and material qualification. By adding Catalent’s off-the-shelf pHelper and rep/cap plasmids, along with a new, in-house clonal HEK293 production cell line, processes can now benefit through increased consistency and efficiency, potentially reducing the time to manufacture clinical-quality drug product to just nine months.

“Speed to patients is paramount for gene therapy innovators, and as such, we’ve seen multiple customers requesting and signing up for the UpTempo platform. We are pleased to now include HEK293 producer cell line and off-the-shelf plasmids as part of the platform, enabling improved efficiency and simplicity for our customers as they prepare to enter clinical trials,” said Manja Boerman, PhD, President, BioModalities (Cell, Gene and Protein Therapies) at Catalent. “Having a partner that offers end-to-end solutions provides security of supply, can eliminate time-consuming tech transfers between companies, optimizes the development steps, and ensures seamless transition from development through to commercial-scale manufacturing.”

Catalent’s global network of pDNA and viral vector clinical and commercial facilities offers horizontally integrated solutions to support advanced therapy programs from gene to clinic. Its Maryland-based network includes a viral vector development facility in Baltimore and CGMP commercial 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 Catalent’s European Center of Excellence in Gosselies, Belgium.

 Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies and viral vectors, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, and oncolytic viruses. An experienced and innovative partner, Catalent Cell & Gene Therapy has a global network of dedicated development, clinical and commercial manufacturing facilities for small- and large-scale programs.

 Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, NJ, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, visit www.catalent.com.