Charles River Laboratories International has announced a strategic partnership with Akadeum Life Sciences to integrate advanced cell separation technology into its Cell Therapy Flex Platform, marking a significant step forward in addressing manufacturing challenges that have long plagued the cell therapy industry.
The collaboration centers on incorporating Akadeum's GMP-grade Human T Cell Leukopak Isolation Kit into Charles River's established Cell Therapy Flex Program, which provides off-the-shelf solutions for autologous CAR-T and TCR-T cell therapy development.
Revolutionary Microbubble Technology
Akadeum's Human T Cell Leukopak Isolation Kit introduces a novel approach to cell separation through its patented Microbubble technology. The system leverages buoyancy principles, using microbubbles to effectively float unwanted cells to the surface while isolating target T cells through gravity-based separation.
"Akadeum's Microbubble technology provides an innovative solution for cell separation, utilizing gravity to isolate T cells. This method is scalable and GMP, ensuring efficiency and quicker delivery to patients," said Kerstin Dolph, Corporate Senior Vice President, Global Manufacturing at Charles River.
The technology offers several operational advantages, requiring no capital investment in new equipment or additional laboratory space. Procedures can be performed directly in the apheresis bag provided within the kit, significantly simplifying workflows while maintaining GMP compliance standards.
Addressing Manufacturing Economics
The partnership directly tackles one of the most pressing challenges in cell therapy development: manufacturing economics. Brandon McNaughton, CEO of Akadeum, emphasized the significance of this collaboration in overcoming industry barriers.
"Cell therapy is transforming medicine, but the economics of manufacturing remain a major barrier. Our work with Charles River and the Flex platform allows us to tackle these challenges head-on, delivering healthier cells, faster processing times, and scalable separations that reduce complexity," McNaughton stated.
Enhanced Platform Capabilities
Charles River's Cell Therapy Flex Platform originated as a comprehensive solution for cell therapy process development, providing ready-to-use platforms and protocols validated for autologous CAR-T and TCR-T cell therapies. The platform encompasses automated, closed-system processes including cell selection and expansion, electroporation, viral vector methods, wash/concentration, and fill-and-finish operations.
The integration of Akadeum's technology represents the latest evolution of the platform. Earlier this year, Charles River had already enhanced the system by incorporating Akron Bio's Closed System Solutions (CSS)™ line of liquid cytokines, produced under current good manufacturing practices (CGMP).
Clinical Impact and Future Implications
The enhanced cell viability achieved through Akadeum's Microbubble technology could have significant implications for patient outcomes. By improving the quality of separated T cells while reducing processing complexity, the technology addresses critical bottlenecks in cell therapy manufacturing that have limited scalability and increased costs.
The collaboration reflects growing industry demand for efficient, cost-effective solutions in the rapidly expanding cell therapy market, as companies seek to balance innovation with scalable production capabilities. The partnership positions both companies to better serve pharmaceutical and biotechnology clients working to accelerate cell therapy development and manufacturing processes.
