Charles River and Akron Bio collaborate to enhance cell therapy manufacturing
Charles River Laboratories International, Inc. and Akron Bio have unveiled a partnership that is poised to redefine cell therapy manufacturing. By integrating Akron Bio’s Closed System Solutions (CSS) line of CGMP liquid cytokines into Charles River’s Cell Therapy Flex Platform, this collaboration aims to streamline production processes, enhance efficiency, and ultimately improve patient safety.
This development leverages advanced manufacturing technologies, addressing critical industry challenges such as cost, scalability, and operational risk. With cell and gene therapies emerging as transformative treatments, the partnership positions Charles River and Akron Bio at the forefront of innovation in therapeutic manufacturing.
What is the significance of CGMP materials in cell therapy manufacturing?
The adoption of current good manufacturing practice (CGMP) materials in cell therapy manufacturing ensures compliance with rigorous quality and safety standards. Akron Bio’s CGMP-grade cytokines, including rHu IL-2, IL-7, IL-15, and IL-21, provide a critical advantage by enabling aseptic processes in closed systems.
These cytokines are formulated to maintain stability at 2–8°C and are delivered in single-use bags with weldable tubing, reducing the risk of operator error. Such advancements support seamless media formulation while ensuring consistency and robustness in therapeutic production.
David Smith, President and Chief Commercial Officer of Akron Bio, highlighted the collaboration’s impact, stating, “By incorporating our CSS cytokines into Charles River’s platform, we are driving advancements in safety, efficiency, and scalability for cell therapy manufacturing.”
How does the Cell Therapy Flex Platform simplify manufacturing processes?
Charles River’s Cell Therapy Flex Platform is designed as a plug-and-play solution for cell therapy process development. Its protocols are validated for CAR-T and TCR-T therapies, making it an invaluable tool for developers aiming to accelerate production timelines while minimizing risks.
The platform integrates automation and closed system technologies for critical manufacturing steps such as cell selection, expansion, electroporation, and fill-finish processes. By incorporating Akron Bio’s CGMP cytokines, the platform offers enhanced reliability, significantly reducing manual interventions and labor requirements.
Kerstin Dolph, Corporate Senior Vice President of Global Manufacturing at Charles River, emphasized the importance of this integration, stating, “Cytokines are fundamental to the success of CAR-T and TCR-T therapies. This collaboration simplifies manufacturing while ensuring process robustness, ultimately safeguarding patient outcomes.”
Why are closed system solutions essential for advanced therapies?
Closed system solutions (CSS) have emerged as a critical component in the evolution of cell therapy manufacturing. These systems reduce the potential for contamination and variability by eliminating open handling steps during production.
Akron Bio’s CSS technology aligns seamlessly with Charles River’s automated processes, enabling a fully enclosed, aseptic workflow. This approach not only enhances efficiency but also mitigates risks associated with human error.
Alex Sargent, Director of Process Development at Charles River, underscored the collaboration’s broader impact, saying, “Closed system automation combined with CGMP-ready materials enables us to scale manufacturing effectively while improving the safety and efficacy of cell therapies.”
How does this collaboration advance cell and gene therapy development?
The integration of Akron Bio’s CGMP cytokines reflects a shared commitment to addressing the challenges of cell and gene therapy production. In recent years, Charles River has expanded its capabilities through strategic acquisitions and investments, catering to the growing demand for plasmid DNA, viral vectors, and cell therapy services.
This collaboration complements Charles River’s “concept-to-cure” approach, offering end-to-end solutions that simplify supply chains and accelerate therapeutic innovation. Akron Bio’s extensive portfolio, including recombinant proteins and precision gene-editing tools, further enhances the platform’s versatility and appeal to advanced therapy developers.
Why does this partnership matter for the future of cell therapy?
As the global demand for cell and gene therapies surges, manufacturing efficiency, scalability, and regulatory compliance remain pivotal challenges. By integrating Akron Bio’s CGMP-grade materials into its Flex Platform, Charles River is setting new benchmarks for streamlined, robust manufacturing.
This collaboration not only enhances production efficiency but also reaffirms the industry’s commitment to advancing patient safety and therapeutic efficacy. With their combined expertise, Charles River and Akron Bio are well-positioned to lead the next wave of innovation in cell therapy manufacturing.
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