The facility represents one of the largest commercial-scale operations in the world.
Catalent – a company aiming to boost the supply of better patient treatments – has announced the opening of a new commercial-scale cell therapy manufacturing facility at its European center of excellence for cell Therapy in Belgium.
The new facility becomes 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 US Food and Drug Administration (FDA) compliant, with grade B and C suites to accommodate bioreactor-scale cell therapy manufacturing as well as on-site quality control (QC) laboratories.
The building is the latest addition to Catalent’s existing Gosselies campus, which already includes a 67,000-square-foot clinical manufacturing facility specialising in advanced clinical and commercial supply solutions.
The Gosselies campus also includes separate plasmid DNA development and manufacturing units. The clinical-scale facility, at 17,000 square feet, includes R&D and process development labs.
Meanwhile, the company’s cell therapy portfolio currently includes several cell types, including CAR-Ts, T-cell receptors, tumor-infiltrating lymphocyte cells, natural killer cells, induced pluripotent stem cells (iPSC) and mesenchymal stem cells.
Manja Boerman, Catalent’s President, reflected: “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 Princeton, New Jersey.”
“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.”