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Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA.
Charles River announced on August 9, 2022 that it has received approval from the European Medicines Agency (EMA) to commercially produce allogeneic cell therapy drug products for distribution in Europe. Its contract development and manufacturing (CDMO) facility located in Memphis, TN received Good Manufacturing Practice (GMP) certification, joining the company’s existing GMP license for Investigational Medicinal Product (IMP) production.
The Memphis facility can now manufacture and ship drug products intended for distribution in the European Union, making it the first CDMO in North America to be awarded the license to do so. The approval follows an inspection by the cell and gene therapy experts from the Italian inspectorate, Agenzia Italiana del Farmaco (AIFA), performed on EMA’s behalf.
“We are incredibly proud that our Memphis facility has received EMA approval to commercially manufacture an allogeneic cell therapy,” said Birgit Girshick, corporate executive vice president & chief operating officer, Charles River, in a company press release. “We are looking forward to continuing close partnerships with our clients, and supporting future commercial projects, bringing these potentially curative therapies to patients, sooner.”
Source: Charles River