Catalent opens one of largest cell therapy manufacturing facilities in the world
Posted: 9 December 2022 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
Sited in Belgium, Catalent has opened one of the largest commercial-scale cell therapy manufacturing facilities in the world.
Credit: JHVEPhoto / Shutterstock.com
Catalent, a contract manufacturing organisation (CMO), has opened one of the largest commercial-scale cell therapy manufacturing facilities in the world, at its European Center of Excellence for Cell Therapies in Gosselies, Belgium.
The 60,000 square foot (5,600 square metre) new state-of-the-art facility houses multi-product, segregated suites facilitates autologous and allogeneic cell therapy manufacturing through to late-stage clinical and commercial-scale supply.
The site 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 in addition to on-site quality control (QC) laboratories and warehousing.
Manufacturing facilities at the Gosselies campus
The Gosselies campus has process and analytical development labs, over 20 Current Good Manufacturing Practice (CGMP) grade B and C cleanrooms, dedicated QC labs, qualified person (QP) services, and warehousing.
The campus also includes separate plasmid DNA (pDNA) development and manufacturing facilities. The 17,000 square foot (1,600 square metre), clinical-scale pDNA facility includes R&D, process development, QC labs, and multiple CGMP production suites. The commercial-scale pDNA facility, offering large-scale manufacturing, is 32,400 square feet (3,010 square metres) in size.
Catalent cell therapy manufacturing
Catalent has expertise in viral vector development, scale-up and manufacturing for gene therapies and viral vaccines. The company is a full-service partner in plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, and oncolytic viruses.
The company has cell and gene therapy facilities in Düsseldorf, Germany, Gosselies in Belgium and Princeton, New Jersey.