If you do not receive an ATOL Certificate then the booking will not be ATOL protected. This website will provide you with information on the protection that applies in the case of each flight before you make your booking. Some of the flights on this website are also financially protected by the ATOL scheme, but ATOL protection does not apply to all flights. If you do receive an ATOL Certificate but all the parts of your trip are not listed on it, those parts will not be ATOL protected. Please ask for it and check to ensure that everything you booked (flights, hotels and other services) is listed on it. When you pay you will be supplied with an ATOL Certificate. To learn more about our unique portfolio and breadth of services, visit View source version on : Ĭorporate Vice President, Investor Contact:Ĭorporate Vice President, Chief Communications Charles River Laboratories, International Inc.All the flight-inclusive holidays on this website are financially protected by the ATOL scheme. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. We are excited to be the first CDMO in North America to reach this milestone.” –Will Isom, Site Director, Memphis, Charles RiverĬharles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. “Our team in Memphis has worked extremely hard to successfully complete the EMA inspection and authorization process. We are looking forward to continuing close partnerships with our clients, and supporting future commercial projects, bringing these potentially curative therapies to patients, sooner.” – Birgit Girshick, Corporate Executive Vice President & Chief Operating Officer, Charles River “We are incredibly proud that our Memphis facility has received EMA approval to commercially manufacture an allogeneic cell therapy. These capabilities have been integrated with Charles River’s legacy services resulting in a “concept-to-cure” cell and gene therapy portfolio. 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). The approval recognizes Charles River’s industry-leading expertise, multidisciplinary team, regulatory know-how, and quality standards.Ĭharles 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. The Memphis site can manufacture and ship drug products intended for European Union distribution. 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 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. (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). 9, 2022-Ĭharles River Laboratories, International Inc. Company awarded commercial GMP license following successful EMA inspection of Memphis CDMO facility
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