Charles River receives Regulatory approval to create allogeneic cell therapy drugs for Europe

Charles River receives Regulatory approval to create allogeneic cell therapy drugs for Europe ...

Charles River Labs received regulatory approvalGood Manufacturing Practice (GMP) accreditation to commercially produce allogeneic cell therapy medication for sale in Europe from the European Medicines Agency (EMA).

The approval comes following a cell and gene therapy specialists performed on the EMAs behalf. Charles RiversMemphis CDMO facility has an existing GMP license for investigational Medicinal Product (IMP) production, according to a company official. The Memphissite is able to manufacture and ship medicines intended for European Uniondistribution.

Charles River's CGMP CDMO facility is designed to produce clinical (early- and late-phase) as well as commercial cell and gene-modified cell therapies. With the addition of Cognate BioServices, Cobra Biologics, and Vigene Biosciences in 2021, Charles River significantly expanded its cell and gene therapy portfolio to include end-to-end CDMO capabilities (plasmid DNA, viral vector, and cellular therapies), according to Birgit Girshick, the corporate executive vice president

OurMemphisfacility has received EMA approval to commercially manufacture an allogeneic cell therapy, and we are looking forward to continuing close relationships with our clients, and supporting future commercial projects, as long as these potentially curative therapies are available to patients, sooner.

Our team inMemphishas worked extremely hard to complete the EMA inspection and authorization process. We are excited to be the first CDMO in North America to reach this milestone, according to Will Isom, the site director,Memphis, and Charles River.

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