Somerset-based Catalent recently announced the opening of a new commercial-scale cell therapy manufacturing facility at its European “centre of excellence for cell therapies” in Belgium.
The new facility will be one of the largest of its type in the world, with 60,000 square feet of cell therapy manufacturing space along with suites designed to support cell therapy manufacturing through to late-stage clinical and commercial-scale supply.
It has also been designed to be both Europe, the Middle East and Africa and U.S. Food and Drug Administration compliant, with grade B and C suites to accommodate bioreactor-scale cell therapy manufacturing as well as on-site quality control laboratories.
“Catalent enables fully integrated cell therapy services — from our iPSC expertise in Düsseldorf, Germany, to process and analytical development in Gosselies (Belgium), to clinical and commercial manufacturing in Gosselies and Princeton, New Jersey — all under one CGMP umbrella,” Manja Boerman, Catalent’s president, BioModalities (Cell, Gene and Protein Therapies), said. “Together with our integrated plasmid DNA and viral vector services, the Catalent Cell & Gene Therapy network provides end-to-end services for development, scale up and commercial launch of advanced therapies.”
The Gosselies campus also includes separate plasmid DNA development and manufacturing units. The clinical-scale facility, at 17,000 square feet, includes research & development and process development labs.