Charles River, a North American-based CDMO, provides essential services and products for pharmaceutical and biotechnology companies to accelerate the research and development of innovative therapies. The recent acquisitions in 2021 of Cognate BioServices, Cobra Biologics and Vigene Biosciences, have enabled Charles River to significantly expand its portfolio, particularly in cell and gene therapies. Today, the CDMO is expanding its activities in Europe. Following an inspection of its Memphis development facility, the company has just been approved by the European regulatory agency EMA. The GMP certification now allows the company to manufacture and market its products in the European Union. A major achievement as Charles River becomes the first US CDMO to reach this milestone.
“We are incredibly proud that our Memphis facility has received EMA approval to commercially manufacture an allogeneic cell therapy. 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