The enhancement of the Memphis site means more cell therapy developers will be able to streamline and accelerate their programs to commercialization with one partner, said the company.
The upgraded facility now sets the bar for clinical- and commercial-scale cell therapy production, it added.
“This expansion marks another significant milestone met by our dedicated experts in Memphis, following our successful EMA inspection and GMP certification,” commented Will Isom, site director, Memphis, Charles River.
The site was the first CDMO in North America to receive European Medicines Agency (EMA) approval to commercially produce allogeneic cell therapy drug products. The newly built suites are online and available for reservation, said Charles River.
The expanded space is suitable for clinical and commercial cell therapy manufacturing, with nine additional processing suites, adding to an existing 16 cleanrooms.
The company said the suites use advanced cleanroom facility technology and design to be fully compliant with current good manufacturing practices (GMP) and international regulatory standards; they 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.”
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. The company said all these capabilities are now fully integrated with the organization’s legacy services resulting in a ‘concept-to-cure’ cell and gene therapy portfolio.