Cellares' Cell Therapy Platform Receives FDA's Advanced Manufacturing Technology Designation

Cellares, a South San Francisco-based biotech company, has achieved a significant milestone in the cell therapy manufacturing landscape. The company's automated cell therapy production platform, known as the Cell Shuttle, has been awarded the coveted Advanced Manufacturing Technology (AMT) designation by the FDA's Center for Biologics Evaluation and Research.

FDA Recognition Bolsters Innovative Manufacturing Approach

The AMT designation, part of a program finalized by the FDA in December 2023, aims to promote the adoption of innovative technologies that can enhance the efficiency, quality, and scalability of drug production processes. To qualify for this designation, companies must demonstrate that their manufacturing approach incorporates new technology or uses established technology in a novel way to substantially improve the production process while maintaining or enhancing product quality.

Fabian Gerlinghaus, Cellares' CEO and co-founder, emphasized the significance of this recognition, stating, "The AMT designation for our Cell Shuttle is a testament to its potential to transform patient outcomes by delivering scalable and cost-effective cell therapy manufacturing to small, early-stage biotechs and large pharma companies with commercialized cell therapies."

The Cell Shuttle: A Factory-in-a-Box Solution

Cellares' Cell Shuttle is a comprehensive end-to-end cell therapy production platform, roughly the size of a truck. It integrates all the necessary technologies for a complete cell therapy manufacturing run into a single piece of equipment. This innovative approach addresses long-standing challenges in cell therapy production, including scalability, labor intensity, and cost.

The platform received current Good Manufacturing Practice (cGMP) certification in March 2023, marking its compliance with rigorous quality standards. With the addition of the AMT designation, the Cell Shuttle is positioned to play a crucial role in streamlining regulatory processes and accelerating development timelines for cell therapies.

Industry Partnerships and Future Implications

Cellares' groundbreaking technology has attracted significant interest from major pharmaceutical companies. In April 2023, Bristol Myers Squibb (BMS) expanded its partnership with Cellares through a $380 million deal, securing manufacturing capacity for its CAR-T therapies, including the established treatments Breyanzi and Abecma, as well as future candidates. This collaboration grants BMS access to Cell Shuttles in the United States, Europe, and Japan.

Similarly, Gilead Sciences' Kite Pharma unit initiated a proof-of-concept evaluation of the Cell Shuttle in June 2023, following a path similar to BMS's initial engagement with Cellares.

These partnerships underscore the industry's recognition of Cellares' potential to address critical production challenges in the rapidly evolving cell therapy field. As the first integrated development and manufacturing organization in the industry, Cellares is well-positioned to drive advancements in cell therapy manufacturing, potentially leading to more accessible and cost-effective treatments for patients worldwide.