Catalent opened a new commercial-scale plasmid DNA (pDNA) manufacturing facility at its European Center of Excellence for Cell Therapies in Gosselies, Belgium. The facility, which contains over 12,000 ft2 (1,100 m2) of development and manufacturing space across multiple cleanrooms for CGMP-grade pDNA production for clinical and commercial-phase supply, 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.
Catalent will also produce a new range of off-the-shelf plasmids to support cell and gene companies,” according to Manja Boerman, PhD, Catalent’s president, BioModalities (Cell, Gene and Protein Therapies). 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.
“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 Boerman. “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, Catalent opened a cell therapy commercial manufacturing facility, also located on the Gosselies campus. It houses 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.