Charles River and Akron Bio Announce Collaboration to Enhance Operations with Integration of CGMP Materials into Cell Therapy Platform

Charles River Laboratories International, Inc. (NYSE: CRL) and Akron Bio ("Akron”), a leading supplier of critical materials and services for advanced therapies, today announced the integration of Akron’s Closed System Solutions (CSS)™ line of liquid cytokines produced under current good manufacturing practices (CGMP) onto Charles River’s Cell Therapy Flex Platform for Process Development. The integration of Akron’s line of liquid cytokines further enables closed system processing, which streamlines operations, minimizes risk, and improves process robustness.

Charles River’s Cell Therapy Flex Platform was designed as an off-the-shelf solution for Cell Therapy Process Development, offering ready-to-use platforms and protocols validated for autologous CAR-T and TCR-T cells therapies to minimize risk, reduce cost, and speed development timelines. Automated platforms with closed systems have protocols ranging from cell selection and expansion to electroporation and wash/concentration to fill and finish.

"With cytokines playing a fundamental role in enhancing CAR-T and TCR-T cell therapies, integrating Akron’s CSS into Charles River’s Flex Platform aims to simplify manufacturing by decreasing labor requirements and improving process robustness, ultimately reducing risk to patients,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing, Charles River.

Charles River’s Cell Therapy Flex Platform has incorporated Akron’s CGMP liquid cytokines, including rHu IL-2, IL-7, IL-15, and IL-21, which are now available in proprietary liquid formulations that maintain the stability of these proteins at 2-8°C. These materials are ready-to-use, available in single-use bags with weldable tubing, thereby minimizing the risk of operator error while enabling rapid, seamless aseptic media formulation.

"Akron Bio is honored to support Charles River’s effort to improve manufacturing efficiency and patient safety by further closing the cell therapy manufacturing process with our CSS cytokines,” said David Smith, President and Chief Commercial Officer, Akron.

"We’re excited to enhance our Cell Therapy Flex Platform offerings with closed system automation that scales manufacturing while working to improve the safety and efficacy of the drug product,” said Alex Sargent, Director of Process Development, Charles River. "With Akron Bio’s CSS line, we can provide customers CGMP ready critical raw materials already on file with the FDA.”

Cell and Gene Therapy CDMO Solutions
In recent years, Charles River has significantly broadened its cell and gene therapy portfolio with several acquisition integrations and expansions to simplify complex supply chains and meet growing demand for plasmid DNA, viral vector, and cell therapy services. Combined with the Company’s legacy testing capabilities, Charles River offers an industry-leading "concept-to-cure” advanced therapies solution.

Schedule a meeting with a Charles River expert at Advanced Therapies Week, January 20-23, 2025, in Dallas, TX to learn more about our cell therapy development and manufacturing capabilities and how our end-to-end CDMO offerings can support your program from concept to cure: https://bit.ly/4ghr2gN

About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

About Akron Bio
Akron Bio enables the advancement of cell and gene therapies through its portfolio of cytokines and media supplements, as well as its comprehensive suite of manufacturing services, including the production plasmid DNA, precision gene editing tools, recombinant proteins and specialized reagents. Akron partners with advanced therapy developers, providing them critical materials and services at the scale, level of compliance, and with the regulatory support necessary to drive novel treatments from discovery to commercialization, thereby addressing critical unmet needs in the patient community. For more information, please visit www.akronbiotech.com.

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