Charles River Laboratories International has expanded 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 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 have options for dual production lines for late-stage clinical- and commercial manufacture.
The expansion incorporates a full containment design of the suites, each with dedicated air handling to prevent cross-contamination, and templated two-dimensional modular construction for a compliant flow of materials and personnel that minimises risk to the 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 programme(s) to commercialisation with one partner, expanding access to needed transformative medicines to patients across the globe.
The announcement follows the Memphis facility being named 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.
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