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Enhancing the Cell Therapy Flex Platform
Transforming cell therapy manufacturing through closed system automation
As the number of cell therapies hitting the market continues to climb, technology and CDMO providers are grappling with how to overcome manufacturing barriers to bring more life-saving treatments to patients faster.
For Charles River and Akron Bio, closed system automation is one of the innovations that will bridge the manufacturing and scaling gaps, allowing drug developers to reduce costs and save time while producing a better product.
As part of a paradigm shift in cell therapy manufacturing, the two companies announced the integration of Akron Bio's Closed System Solution (CSS)™ line of liquid good manufacturing practice (CGMP) cytokines onto Charles River's Cell Therapy Flex Platform for Process Development.
The integration enables closed system processing of critical raw materials that streamlines operations, minimizes risk, and improves process robustness.
"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, Akron Bio's President and Chief Commercial Officer, in a press release.
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Improving Cell Therapies for Patients
Akron Bio, a leading supplier of critical materials and services for advanced therapies, offers cytokines in a liquid format that eliminates the need for reconstitution.
Furthermore, the Florida-based company has transitioned its liquid cytokines into a closed system format called the Closed System Solution (CSS)™ line, offering several fill volumes and weldable tubing options.
Not only does this system eliminate the challenges associated with reconstituting lyophilized materials, ensuring material integrity after a freeze-thaw cycle, and maintaining post-reconstitution stability, it also enables seamless aseptic media formulation, thereby reducing the risk of possible contamination.
Charles River's Cell Therapy Flex Platform has incorporated Akron Bio'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.
"With cytokines playing a fundamental role in enhancing CAR-T and TCR-T cell therapies, integrating Akron Bio'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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GMP Ready Speeds Time to Market for CAR-T Manufacturing
Launched in 2024, 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 cell therapies.
Similar to Akron Bio's CSS line, the Flex Platform was designed to minimize risk, reduce cost, and speed development timelines for drug developers from months to weeks. These automated platforms with closed systems have protocols that range from cell selection and expansion to electroporation and wash/concentration to fill and finish.
Because of the closed processing system, the cell therapy platforms feature state-of-the-art equipment and modalities that can flex from small projects with short timelines to large batches that span several weeks.
With the integration of Akron Bio's CGMP liquid cytokines, the process is further streamlined as a Drug Master File with the FDA is available for each CSS product, allowing for seamless regulatory support for CAR-T therapies.
"We're excited to enhance our Cell Therapy Flex Platform offerings with closed system automation that scales manufacturing while improving 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 GMP-ready critical raw materials already on file with the FDA."