{"id":47084,"date":"2022-08-09T14:01:42","date_gmt":"2022-08-09T12:01:42","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/charles-river-laboratories-is-first-cdmo-in-north-america-to-receive-ema-approval-to-commercially-produce-an-allogeneic-cell-therapy-drug-product\/"},"modified":"2022-08-09T14:01:42","modified_gmt":"2022-08-09T12:01:42","slug":"charles-river-laboratories-is-first-cdmo-in-north-america-to-receive-ema-approval-to-commercially-produce-an-allogeneic-cell-therapy-drug-product","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/charles-river-laboratories-is-first-cdmo-in-north-america-to-receive-ema-approval-to-commercially-produce-an-allogeneic-cell-therapy-drug-product\/","title":{"rendered":"Charles River Laboratories is First CDMO in North America to Receive EMA Approval to Commercially Produce an Allogeneic Cell Therapy Drug Product"},"content":{"rendered":"
\n

\nCompany awarded commercial GMP license following successful EMA inspection of Memphis CDMO facility<\/i>\n<\/p>\n

MEMPHIS, Tenn.–(BUSINESS WIRE)–$CRL<\/a> #LIFEatCRL<\/a>–Charles River Laboratories, International Inc. (NYSE: CRL) announced it 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).\n<\/p>\n

<\/a><\/p>\n

\nThe approval follows an inspection by the cell and gene therapy experts from the Italian inspectorate, Agenzia Italiana del Farmaco (AIFA), performed on the EMA\u2019s behalf. The GMP certification of Charles River\u2019s 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\u2019s industry-leading expertise, multidisciplinary team, regulatory know-how, and quality standards.\n<\/p>\n

\nCharles River\u2019s Memphis CGMP CDMO facility<\/a> 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\u2019s legacy services resulting in a \u201cconcept-to-cure\u201d cell and gene therapy portfolio.\n<\/p>\n

\nApproved Quotes<\/b>\n<\/p>\n