International pharmaceutical developer Charles River has announced the expansion of its cell therapy contract development and manufacturing (CDMO) facility in Memphis, U.S.
This new space will build upon Charles River’s current services delivering the safe development and manufacturing of new therapies for patients. With its 2021 acquisitions of Cognate BioServices, Cobra Biologics, and Vigene Biosciences facilitating the inclusion of cell and gene therapy end-to-end CDMO capabilities into its ‘concept-to-cure’ portfolio.
Nine state-of-the-art processing suites will add to the existing sixteen cleanrooms available on-site for clinical and commercial cell therapy manufacturing.
Built according to advanced cleanroom facility technology and design these suites are fully compliant with good manufacturing practices (GMP) and international regulatory standards, as well as offering a high level of flexibility to support client requirements, including high-volume production, dual production lines and translational support.
“This expansion marks another significant milestone met by our dedicated experts in Memphis, following our successful EMA inspection and GMP certification. We are incredibly proud of our industry-leading team and facility in Memphis. We are excited for the opportunities this expansion will afford, as the industry has responded positively, with a meaningful portion of suites being already reserved,” said Will Isom, Site Director, Memphis, Charles River.
Alongside key equipment including centrifuges and incubators, Charles River will provide bespoke suites fitted with client-specific equipment to enable end-to-end production. Every suite also features template two-dimensional modular construction to enable the compliant flow of materials and personnel, as well as dedicated air handling to prevent cross-contamination.
Charles River has announced that these newly built specialized suites at its Memphis facility are currently online and available for immediate reservation by developers aiming to streamline and accelerate their transformative therapy programs.
This expansion follows the facility’s achievement in becoming the first CDMO in North America to gain EMA approval to commercially produce allogeneic cell therapy drug products – as the demand for these, alongside other advanced therapeutic, products, continues to grow around the globe.
In light of their news, the team at Charles River told Phacilitate “Since last year, our team has been proud to provide clients with end-to-end CDMO capabilities, and our facility in Memphis is an important partner in bringing potentially curative therapies to patients sooner. This expansion allows us to partner with more cell therapy developers, and we are excited about the opportunity to grow our team and continue our work on transformative medicines in development.”