Charles River Laboratories International, Inc. and Akron Bio, a leading supplier of critical materials and services for advanced therapies, 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.
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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.”
SOURCE: Businesswire