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Complex to develop cGMP-compliant, commercial-scale plasmid DNA.
Catalent, a contract development and manufacturing organization (CDMO), is opening a new commercial-scale plasmid DNA (pDNA) facility at its European “center of excellence” for cell therapies in Gosselies, Belgium. Designed to be European Medicines Agency (EMA) and FDA compliant, this 12,000 square-foot location will be dedicated to current good manufacturing practice (cGMP) pDNA production for clinical and commercial-phase supply.
At the new facility, the CDMO plans to produce a new range of plasmids to support cell and gene companies, including adeno-associated virus (AAV) pHelper, along with Rev/Cap AAV2 and AAV5 plasmids. As the latest addition to the Gosselies campus, Catalent states that the location 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,” says Manja Boerman, PhD, Catalent’s president of biomodalities. “…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.”
Read more about the new facility here.