Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, announced the opening of a new commercial-scale plasmid DNA (pDNA) manufacturing facility at its European center of excellence for cell therapies, in Gosselies, Belgium.
The state-of-the-art facility contains over 12,000 square feet (1,100 square meters) of development and manufacturing space across multiple cleanrooms for the dedicated production of CGMP-grade pDNA for clinical and commercial-phase supply. It has been designed to be EMA and FDA compliant to support customers with requirements for high-yielding processes at 50 and 300-liter fermentation scale. This will enable a wide range of batch sizes from milligram to multi gram scale.
At the new facility, Catalent will also produce a new range of ‘off-the-shelf’ plasmids to support cell and gene companies. These include adeno-associated virus (AAV) pHelper, which is available now, and Rep/Cap AAV2 and AAV5 plasmids, which will be available later this quarter. Rep/Cap AAV serotypes 1, 3, 6 and 10 will be available later this year.
This commercial-scale pDNA facility is the latest addition to Catalent’s Gosselies campus, which provides comprehensive services for all stages of cell and gene therapy development, including process and analytical development laboratories, technical transfer services, CGMP cleanrooms for manufacturing, dedicated quality control laboratories, Qualified Person (QP), as well as warehousing and logistics support.
“Catalent enables fully integrated viral vector and mRNA services—from our pDNA expertise in Gosselies, to clinical and commercial production of viral vectors for gene therapy, cell therapy, and mRNA in our network—providing critical supply chain continuity and a single CDMO partner from lead identification to commercial manufacturing,” said Manja Boerman, Ph.D., Catalent’s President, BioModalities (Cell, Gene and Protein Therapies). “Plasmid DNA is a critical component to many biological therapeutics, and Catalent has made this investment in additional manufacturing capacity in anticipation of supporting the growing number of programs through development towards commercialization.”
In December 2022, Catalent opened one of the world’s largest cell therapy commercial manufacturing facilities, also located on the Gosselies campus. The facility houses 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.
