Catalent Opens One of the World’s Largest Commercial-Scale Cell Therapy Manufacturing Facilities at its European Center of Excellence for Cell Therapies in Belgium

Catalent recently announced the completion and opening of 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-sq-ft (6,200-sq-m) 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.

Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies and viral vaccines, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, and oncolytic viruses. As an experienced and innovative partner, it has a global network of dedicated, development, clinical, and commercial manufacturing facilities, including an EMA- and FDA-licensed viral vector facility, and fill/finish capabilities located in the U.S. and Europe. With integrated solutions for plasmid DNA, viral vectors, and autologous and allogeneic cell therapies through clinical trial packaging and logistics, Catalent can provide full supply chain control, helping innovators get their advanced therapies to patients, faster.

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, NJ, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information, visit www.catalent.com.