Catalent has completed and opened a new commercial-scale cell therapy manufacturing facility at its European center of excellence for cell therapies, in Gosselies, Belgium.
The new state-of-the-art facility will be one of the largest in the world, with 60,000 square feet (5,600 square meters) of dedicated cell therapy manufacturing space housing multi-product, segregated suites designed to support autologous and allogeneic cell therapy manufacturing through to late-stage clinical and commercial-scale supply.
The facility has been designed to be EMEA and FDA compliant, with Grade B and C suites to support high-throughput processes and accommodate bioreactor-scale cell therapy manufacturing as well as on-site quality control (QC) laboratories and warehousing.
The newly completed facility is the latest addition to Catalent’s Gosselies campus, which already includes a 67,000-square-foot (6,200-square-meter) clinical manufacturing facility offering customers advanced clinical and commercial supply solutions. The overall Gosselies campus provides a one-stop shop, with process and analytical development labs, more than 20 CGMP grade B and C cleanrooms, dedicated QC labs, qualified person (QP) services, and warehousing.
“Catalent enables fully integrated cell therapy services—from our iPSC expertise in Düsseldorf, Germany, to process and analytical development in Gosselies, to clinical and commercial manufacturing in Gosselies and Princeton, New Jersey—all under one CGMP umbrella,” said Manja Boerman, Catalent’s president, BioModalities (Cell, Gene and Protein Therapies). “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 (pDNA) development and manufacturing facilities. The clinical-scale pDNA facility, at 17,000 square feet (1,600 square meters), includes R&D, process development, QC labs, and multiple CGMP production suites. The commercial-scale pDNA facility, at 32,400 square feet (3,010 square meters), offers large-scale manufacturing.