A little over a year after winning manufacturing certification for its cell therapy factory-in-a-box, South San Francisco’s Cellares has passed another major production milestone.
Cellares’ automated cell therapy production platform, known as the Cell Shuttle, has received a coveted advanced manufacturing technology (AMT) designation from the FDA’s Center for Biologics Evaluation and Research, the company announced this week.
Cellares—which pitches itself as the industry’s first integrated development and manufacturing organization—says the designation should bolster the adoption of innovative technologies, like the Cell Shuttle, that have the potential to boost the efficiency, quality and scalability of cell therapies.
The manufacturing platform itself, which earned a current good manufacturing practice (cGMP) seal of approval last March, is about as big as a truck and combines all the technologies needed to complete an end-to-end cell therapy production run in a single piece of equipment, Cellares has explained.
After initially floating a framework for the classification in late 2023, the FDA in December released its final guidance on the AMT designation program.
To qualify for AMT designation, a company—be it a drugmaker, contract manufacturer or technology developer—must present a manufacturing approach that incorporates a new technology or uses an established technology in a novel way to substantially improve the production process for a drug while maintaining or enhancing its qualities, according to the FDA’s guidance.
The FDA’s criteria for inclusion in the AMT club also covers technologies that cut development timelines or boost supplies of drugs that are critical or in shortage.
“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,” Fabian Gerlinghaus, Cellares’ CEO and co-founder, said in a statement about the new FDA classification.
AMT designations have many benefits, according to the FDA, including the potential to provide greater quality assurance, help the industry “more efficiently” meet regulatory standards for commercial manufacturing and strengthen “regulatory predictability” for products using the platforms, the agency explained in its guidance document.
Cellares, six years into its run, has attracted some impressive partners eager to get their hands on the startup’s automated approach to cell therapy. Production of cell therapies has long been a limiting factor for the field, with scalability, labor intensity and cost frequently cited as pain points by manufacturers.
Last April, Bristol Myers Squibb expanded an ongoing partnership with Cellares through a $380 million deal to reserve manufacturing space for CAR-T therapies. The deal, which includes both upfront and future milestone payments, grants BMS access to an undisclosed number of Cellares’ Cell Shuttles in the U.S., Europe and Japan, the companies said at the time.
BMS, for its part, said the collaboration will boost capacity for its established CAR-T treatments Breyanzi and Abecma plus future cell therapy candidates.
Just a few months later, in June, Gilead Sciences’ Kite Pharma unit linked up with Cellares in a proof-of-concept evaluation of the Cell Shuttle to determine whether the platform could be a viable option for Kite. The path is similar to that which BMS followed before stepping up its Cellares commitment with a full-on manufacturing pact last year.