Charles River Laboratories International, Inc. announced the expansion of its cell therapy contract development and manufacturing (CDMO) facility in Memphis, Tenn. The expanded space is suitable for clinical and commercial cell therapy manufacturing, with an additional nine (9) state-of-the-art processing suites, adding to an existing 16 cleanrooms.
The suites use advanced cleanroom facility technology and design to be fully compliant with current good manufacturing practices (GMP) and international regulatory standards, can accommodate flexible configurations to support client requirements, and are configured for high volume production, and options for dual production lines for late stage clinical- and commercial manufacture. The expansion incorporates full containment design of the suites, each with dedicated air handling to prevent cross-contamination, and templated two-dimensional modular construction for compliant flow of materials and personnel that minimizes risk to product, enabling repeatable results. Cleanrooms are fitted with key equipment, including centrifuges and incubators as standard, with client-specific, bespoke equipment available as required.
The Memphis CDMO facility expansion enables more cell therapy developers to streamline and accelerate their program(s) to commercialization with one partner, expanding access of needed transformative medicines to patients across the globe. This announcement follows the Memphis facility being named as the first CDMO in North America to receive EMA approval to commercially produce allogeneic cell therapy drug products. The newly built suites are online and available for reservation immediately.
The Memphis GMP CDMO facility supports the manufacture of 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). These capabilities are fully integrated with Charles River’s legacy services resulting in a “concept-to-cure” cell and gene therapy portfolio.
“This expansion builds on the Memphis site’s demonstrable expertise and commitment to supporting cell and gene therapy clients from early target identification through clinical and commercial-scale manufacturing. We look forward to continuing close partnerships with our clients and supporting projects to bring these potentially curative therapies to patients.” – Birgit Girshick, Corporate Executive Vice President & Chief Operating Officer, Charles River
“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.”–Will Isom, Site Director, Memphis, Charles River