Processes can now benefit through increased consistency and efficiency, potentially reducing the time
Catalent has expanded 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.
The company launched its UpTempo platform in 2022, to standardise 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.
Having a partner that offers end-to-end solutions provides security of supply, can eliminate time-consuming tech transfers
“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, optimises 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.