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Somerset-based Catalent announced Thursday that it has opened a new commercial-scale plasmid DNA manufacturing facility in Gosselies, Belgium.
The state-of-the-art facility includes over 12,000 square feet of development and manufacturing space across multiple cleanrooms, with dedicated production of current Good Manufacturing Practice grade pDNA for clinical and commercial stage supplies. increase.
Designed to be fully compliant with the European Medicines Agency and the Food and Drug Administration and supporting customers with high yield process requirements on 50 and 300 liter fermentation scales, the new facility offers a wide range of milligram to multigram Allow batch size. scale.
Catalent said it will also manufacture a new range of “off-the-shelf” plasmids to support cell and gene companies.
This commercial-scale pDNA facility is a recent addition to Catalent’s Gosselies campus, providing comprehensive services for all stages of cell and gene therapy development.
“Catalent enables a fully integrated viral vector and mRNA service. This translates from pDNA expertise at Gosselies into clinical and It provides critical supply chain continuity and a single CDMO partner from lead to commercial production,” said Manja Boerman, President of Biomodality at Catalent. . “Plasmid DNA is a critical component to many biological therapeutics and Catalent has made this investment in additional manufacturing capacity in the hope that it will support its growing program through development towards commercialization. rice field.”
In December 2022, Catalent will open one of the world’s largest commercial cell therapy manufacturing facilities at its Gosselier campus. The facility has 60,000 square feet of dedicated cell therapy manufacturing space, housing a multi-product segregated suite designed to support autologous and allogeneic cell therapy manufacturing.
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