Catalent reported that it 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 facility encompasses 60,000 ft2 (5,600 m2) 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, which 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, is the latest addition to Catalent’s Gosselies campus, which already includes a 67,000 ft2 (6,200 m2) clinical manufacturing facility offering advanced clinical and commercial supply solutions.
The overall Gosselies campus provides process and analytical development labs, more than 20 CGMP grade B and C cleanrooms, dedicated QC labs, qualified person (QP) services, and warehousing, according to Manja Boerman, Catalent’s president, BioModalities (Cell, Gene, and Protein Therapies).
“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,” added Boerman. “Together with our integrated plasmid DNA and viral vector services, the Catalent Cell & Gene Therapy network provides end-to-end services for development, scaleup, 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 ft2 (1,600 m2), includes R&D, process development, QC labs, and multiple CGMP production suites. The commercial-scale pDNA facility, at 32,400 ft2 (3,010 m2), offers large-scale manufacturing.