Charles River Labs received regulatory approval—Good Manufacturing Practice (GMP) certification—to commercially produce allogeneic cell therapy drug products for distribution 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 CDMO facility complements an existing GMP license for Investigational Medicinal Product (IMP) production, according to a company official, who added that the Memphis site can manufacture and ship drug products intended for European Union distribution.
Charles River’s Memphis CGMP CDMO facility is designed 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), noted Birgit Girshick, corporate executive vice president and COO, Charles River.
“We are incredibly proud that our Memphis facility has received EMA approval to commercially manufacture an allogeneic cell therapy,” continued Girshick. “We are looking forward to continuing close partnerships with our clients, and supporting future commercial projects, bringing these potentially curative therapies to patients, sooner.”
“Our team in Memphis has worked extremely hard to successfully complete the EMA inspection and authorization process. We are excited to be the first CDMO in North America to reach this milestone,” added Will Isom, site director, Memphis, Charles River.