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Catalent is expanding its UpTempo AAV platform to accelerate the development of gene therapies.
Catalent announced on March 9, 2023 the expansion of its UpTempo platform process for the development and current good manufacturing practice 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 implement a single, uniform bill of materials to simplify the critical supply chain and material qualification. The new additions aim to increase 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, president, BioModalities (cell, gene, and protein therapies) at Catalent, in a company press release. “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.”