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CDMO Expansion Sets the Bar for Cell Therapy Production
Significant increase in cell therapy capacity reinforces commitment to contract development and manufacturing clients
The expansion of our cell therapy contract development and manufacturing (CDMO) facility in Memphis, Tennessee offers state-of-the-art processing space across nine new suites, adding to an existing 16 cleanrooms. The new suites use advanced cleanroom technology and design to be fully compliant with current good manufacturing practices (CGMP) and international regulatory standards.
With the ability to accommodate flexible configurations to support client requirements, the expansion suites are configured for high-volume manufacturing, with options for dual production lines for late-stage clinical to commercial scale. To minimize risk to product, and enable repeatable results, the expansion also incorporates full containment design, with each suite having dedicated air handling to prevent cross-contamination, and templated two-dimensional modular construction for compliant flow of materials and personnel.
“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.” Commented Birgit Girshick, Charles River Corporate Executive Vice President & Chief Operating Officer, in a press release announcing the capacity increase. “We look forward to continuing close partnerships with our clients and supporting projects to bring these potentially curative therapies to patients.”
The newly-built suites are online and available for reservation immediately.
Cell Therapy Manufacturing Excellence
Our comprehensive package of autologous and allogeneic cell therapy manufacturing services includes GMP production of cells from preclinical to commercial applications from a variety of starting materials.
The Memphis facility expansion enables more cell therapy developers to streamline and accelerate their programs to commercialization with a single, experienced partner, and follows the site being named as the first CDMO in North America to receive EMA approval to commercially produce allogeneic cell therapy drug products.
Will Isom, Site Director of the Memphis facility, shared: “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.”
For more information on our cell therapy development and manufacturing services, please visit: Cell and Gene Therapy CDMO Solutions.
A New Era for Cell Therapy Manufacturing
Memphis facility paves the way to become the first North American CDMO to receive EMA approval for commercial allogeneic cell therapy production.
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