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Pioneering a New Era of Cell Therapy Manufacturing
Memphis facility becomes first North American CDMO to receive EMA approval for commercial allogeneic cell therapy production
Following its successful inspection, our Memphis cell therapy manufacturing facility is paving the way in the cell and gene therapy industry as the first contract development and manufacturing organization (CDMO) in North America to be awarded a commercial GMP license to produce allogeneic cell therapy drug products from the European Medicines Agency (EMA).
“We are incredibly proud that our Memphis facility has received EMA approval to commercially manufacture an allogeneic cell therapy,” commented Birgit Girshick, CEVP & COO, in a press release announcing the news. “We are looking forward to continuing a close partnership with our clients, and supporting future commercial projects, bringing these potentially curative therapies to patients, sooner.”
Cell Therapy Development and Manufacture
Our allogeneic (donor cells) and autologous (patient’s own cells) comprehensive cell therapy manufacturing portfolio of services includes GMP production of cells from a variety of starting materials including immune cell populations (such as T-cells, NKs, Dendritic cells) and stem cells. Our experienced team is well-versed in supporting clients through the development pathway, optimizing development protocols, and securely and swiftly scaling up production from clinical to commercial scale.
Located right next to the largest logistics hub in North America, the Memphis site, purpose-built for GMP cell and gene-modified cell therapy production, was integrated into Charles River’s comprehensive cell and gene therapy portfolio in 2021, with the acquisition of established CDMOs Cognate BioServices and Cobra Biologics.
“Our team in Memphis has worked extremely hard to successfully complete the EMA inspection and authorization process,” remarked Will Isom, Memphis site director. “We are excited to be the first CDMO in North America to reach this milestone.”
For more information on our cell therapy, plasmid DNA, and viral vector development and manufacturing services, please visit: Cell and Gene Therapy CDMO Solutions.
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