Charles River Laboratories, International received regulatory approval, in the form of Good Manufacturing Practice (GMP) certification, to commercially produce allogeneic cell therapy drug products to distribute in Europe, from the European Medicines Agency (EMA).
The approval follows 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 GMP certification of Charles River’s Memphis contract development and manufacturing (CDMO) facility complements an existing GMP license for Investigational Medicinal Product (IMP) production. The Memphis site can manufacture and ship drug products intended for European Union distribution. The approval recognizes Charles River’s industry-leading expertise, multidisciplinary team, regulatory know-how, and quality standards.
Charles River’s Memphis CGMP CDMO facility is suitable to manufacture clinical (early- and late-phase) as well as commercial cell and gene-modified cell therapies. With the 2021 acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences, Charles River significantly expanded its cell and gene therapy portfolio to include end-to-end CDMO capabilities (plasmid DNA, viral vector, and cellular therapies). These capabilities have been integrated with Charles River’s legacy services resulting in a “concept-to-cure” cell and gene therapy portfolio.
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