sa国际传媒官网网页入口Expands UpTempo鈩 AAV Platform to Accelerate Development of Gene Therapies
SOMERSET, N.J. 鈥 March 9, 2023 鈥 Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, today announced the expansion of its UpTempo鈩 聽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.
sa国际传媒官网网页入口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鈥檚 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.
鈥淪peed to patients is paramount for gene therapy innovators, and as such, we鈥檝e seen multiple customers requesting and signing up for the UpTempo platform.聽 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,鈥 said Manja Boerman, Ph.D., President, BioModalities (Cell, Gene and Protein Therapies) at Catalent. 鈥淗aving 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.鈥
Catalent鈥檚 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鈥檚 European Center of Excellence in Gosselies, Belgium.
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ABOUT CATALENT CELL AND GENE THERAPY
sa国际传媒官网网页入口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, sa国际传媒官网网页入口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, sa国际传媒官网网页入口Cell & Gene Therapy has a global network of dedicated development, clinical and commercial manufacturing facilities for small- and large-scale programs.
ABOUT CATALENT
sa国际传媒官网网页入口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, sa国际传媒官网网页入口is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.
sa国际传媒官网网页入口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鈥檚 expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians.
Headquartered in Somerset, New Jersey, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, visit .