Charles River Laboratories' Memphis manufacturing facility has received a certification needed for entry into a key global market.
The Wilmington-based pharma company announced Aug. 9, that its Memphis contract development and manufacturing (CDMO) facility received a good manufacturing practice (GMP) certification from the European Medicines Agency (EMA). That certification enables Charles River to manufacture and ship allogeneic cell therapy drug products for distribution in the European Union market.
According to the company, the move makes the Memphis CDMO facility a trendsetter in receiving this regulatory approval from EMA.
“As the first CDMO in North America approved to commercially produce allogeneic cell therapy drug products, the Memphis facility is now recognized as a global leader in this space,” Will Isom, the Memphis CDMO site director, told the Memphis Business Journal. “Receiving the GMP certification allows [our] Memphis [facility] to manufacture commercial-grade cell therapy drug products for distribution in Europe.”
The Memphis facility works with clients across all disease indications, he said, including oncology, endocrinology, cardiology, hematology, rare disease, and macular disease. With this certification, the site can manufacture and then ship drug products for distribution in the European Union.
As part of the authorization process, cell and gene therapy experts from the Italian medicine agency, Agenzia Italiana del Farmaco (AIFA), conducted an inspection of the Memphis facility on behalf of the EMA, which, Isom said, the facility successfully completed.
"We are extremely proud of our Memphis team for successfully completing the EMA audit," he said. "The process was very thorough, and truly highlighted our industry-leading expertise, multidisciplinary team, regulatory know-how, and quality standards."
According to MBJ research, the CDMO facility at 4600 E. Shelby Dr. has over 300 employees. While Isom didn’t clarify if any new jobs would be added immediately as a result of the newly gained EMA approval and access to the EU market, he said the facility had the capability for growth in both jobs and the scale of production.
“The scale of that production will depend on specific client needs," he said, "and Memphis has the capability to scale with our clients, both in terms of capacity and job growth."
Charles River acquired the facility in April 2021 for approximately $875 million. Before the acquisition, it was the headquarters of Cognate BioServices since 2007. According to the facility overview, the Memphis space has a manufacturing facility of over 100,000 square feet with an expansion facility of 120,000 square feet and a GMP warehouse of about 50,000 square feet.
In an earnings call on Aug. 3, Charles River CEO Jim Foster said that as part of their new strategy for the recently acquired CDMO facilities (Cognate and Vigene), they would be developing "centers of excellence" at the three locations, including one for gene-modified cell therapy production at their Memphis facility.
