Cell Therapy Platform Enhanced: Charles River and Akron Bio Integrate CGMP Materials

Cell Therapy Platform Enhanced: Charles River and Akron Bio Integrate CGMP Materials

Charles River Laboratories International, Inc. (NYSE: CRL) and Akron Bio, a leading supplier of critical materials and services for advanced therapies, have announced a new collaboration to integrate Akron’s Closed System Solutions (CSS)™ line of liquid cytokines into Charles River’s Cell Therapy Flex Platform for Process Development. This integration enhances closed system processing, which streamlines operations, reduces risk, and improves the overall robustness of the process. By incorporating Akron’s CGMP-produced liquid cytokines, the partnership aims to further advance the development of cell therapies with more efficient and secure manufacturing solutions.

This partnership integrates Akron Bio’s Closed System Solutions (CSS)™ line of liquid cytokines into Charles River’s Cell Therapy Flex Platform for Process Development. This integration aims to streamline cell therapy manufacturing, reduce labor requirements, improve process robustness, and, most importantly, reduce patient risk.

The Cell Therapy Flex Platform is designed as an off-the-shelf solution for process development in cell therapy. It offers ready-to-use platforms and validated protocols specifically tailored for autologous CAR-T (Chimeric Antigen Receptor T) and TCR-T (T Cell Receptor T) therapies. The platform covers critical process steps such as cell selection, expansion, electroporation, wash/concentration, and the fill-and-finish process. The ultimate goal is to minimize the risks associated with cell therapy manufacturing, reduce costs, and speed up development timelines. The incorporation of Akron’s CSS cytokines into this platform further enhances the robustness of these processes.

“With cytokines playing a critical role in enhancing CAR-T and TCR-T cell therapies, integrating Akron’s CSS into Charles River’s Flex Platform is a key step toward simplifying manufacturing,” said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing at Charles River. “This partnership will help decrease labor requirements and improve process robustness, all while reducing patient risk.”

The integration includes Akron Bio’s CGMP (current Good Manufacturing Practices) liquid cytokines, such as rHu IL-2, IL-7, IL-15, and IL-21. These cytokines are now available in proprietary liquid formulations that maintain their stability at 2-8°C, ensuring reliable performance in the manufacturing process. The ready-to-use cytokines are provided in single-use bags with weldable tubing, which minimizes the risk of operator error and facilitates rapid, seamless aseptic media formulation. This integration helps create a more efficient and controlled process, which is critical for the production of safe and effective cell therapies.

David Smith, President and Chief Commercial Officer at Akron Bio, expressed excitement about the partnership, stating, “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.” By leveraging Akron’s closed system solutions, Charles River can continue to provide more scalable and streamlined manufacturing options to its customers, reducing complexity and improving consistency.

Alex Sargent, Director of Process Development at Charles River, also shared his enthusiasm about the enhanced platform: “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. With Akron Bio’s CSS line, we can now offer customers CGMP-ready critical raw materials that are already filed with the FDA.” This development ensures that biopharma companies working with Charles River can leverage reliable and compliant materials, enabling faster and more efficient development and manufacturing of cell-based therapies.

Charles River has been steadily expanding its capabilities in cell and gene therapy in recent years. Through strategic acquisitions and partnerships, including this collaboration with Akron Bio, the company has broadened its portfolio to simplify complex supply chains and meet the growing demand for services related to plasmid DNA, viral vectors, and cell therapies. This expansion is in line with Charles River’s commitment to offering an industry-leading “concept-to-cure” solution for advanced therapies. Their comprehensive services help pharmaceutical and biotechnology companies streamline the development process from initial discovery through to commercialization.

As part of its commitment to advancing the field of cell and gene therapy, Charles River will be showcasing its cell therapy development and manufacturing capabilities at Advanced Therapies Week, taking place January 20-23, 2025, in Dallas, TX. The company invites attendees to schedule a meeting with their experts to learn more about the latest innovations in cell therapy manufacturing and how Charles River’s end-to-end contract development and manufacturing organization (CDMO) services can support their therapeutic programs from concept to cure.

About Charles River

Charles River Laboratories is a leading provider of essential products and services designed to accelerate the research and drug development efforts of pharmaceutical and biotechnology companies, government agencies, and academic institutions worldwide. The company focuses on providing clients with the tools they need to improve and expedite the discovery, early-stage development, and safe manufacture of new therapies.

About Akron Bio

Akron Bio is dedicated to advancing cell and gene therapies by offering a wide range of cytokines, media supplements, and manufacturing services. The company’s offerings include plasmid DNA production, precision gene editing tools, recombinant proteins, and specialized reagents. Akron Bio partners with advanced therapy developers to provide critical materials and services that support the scale, compliance, and regulatory needs of novel treatments from discovery through commercialization.

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