Charles River Laboratories becomes first CDMO in North America to receive EMA approval for commercial production of allogenic cell therapy drug product

By Rachel Arthur

- Last updated on GMT

Pic: Charles River
Pic: Charles River

Related tags Charles river laboratories cell and gene therapy Cell therapies Us Ema European medicines agency

Charles River Laboratories, International Inc. has received regulatory approval - in the form of Good Manufacturing Practice (GMP) certification - to commercially produce allogeneic cell therapy drug products for distribution in Europe, from the European Medicines Agency (EMA).

The GMP certification of Charles River’s Memphis CDMO facility complements an existing GMP license for Investigational Medicinal Product (IMP) production. The new approval comes after an inspection by the cell and gene therapy experts from the Italian inspectorate, Agenzia Italiana del Farmaco (AIFA), performed on the EMA’s behalf.

The Memphis site can now manufacture and ship drug products intended for European Union distribution. The CGNP CDMO facility manufactures clinical as well as commercial cell and gene-modified therapies.

Charles River has been expanding its cell and gene therapy portfolio to include end-to-end CDMO capabilities (plasmid DNA, viral vector, and cellular therapies): notably with the 2021 acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences.

Integrated with Charles River’s legacy services, the result is a 'concept-to-cure' cell and gene therapy portfolio, says the company.

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