Somerset-based Catalent on Thursday said it opened a new commercial-scale plasmid DNA manufacturing facility in Gosselies, Belgium.
The state-of-the-art facility contains over 12,000 square feet of development and manufacturing space across multiple cleanrooms for the dedicated production of current good manufacturing practice-grade pDNA for clinical and commercial-phase supply.
Fully designed to be European Medicines Agency- and Food and Drug Administration-compliant to support customers with requirements for high-yielding processes at 50- and 300-liter fermentation scale, the new facility will enable a wide range of batch sizes from milligram to multigram scale.
Catalent said it will also produce a new range of “off-the-shelf” plasmids to support cell and gene companies.
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.
“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,” Manja Boerman, Catalent’s president, biomodalities, said. “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 of dedicated cell therapy manufacturing space housing multiproduct, segregated suites designed to support autologous and allogeneic cell therapy manufacturing.
