Cellares’ Cell Shuttle™ Receives FDA Advanced Manufacturing Technology (AMT) Designation for Automated Cell Therapy Manufacturing

The AMT designation gives Cellares’ clients using the Cell Shuttle priority review with the FDA leading to accelerated regulatory filings

Cellares, the first Integrated Development and Manufacturing Organization (IDMO), proudly announces that its Cell Shuttle™ has been granted the Advanced Manufacturing Technology (AMT) designation by the FDA’s Center for Biologics Evaluation and Research (CBER). This designation acknowledges the Cell Shuttle’s ability to automate and reliably manufacture cell therapies and represents a significant step forward in the advanced manufacturing of cell therapies.

The AMT designation is intended to encourage the adoption of innovative technologies, such as Cellares’ Cell Shuttle, that enhance the efficiency, quality, and scalability of cell therapies. As a result of this designation, developers leveraging Cellares’ IDMO Manufacturing services will receive expedited FDA review, resulting in decreased times to IND and BLA, as well as a streamlined pathway to the approval of additional cell therapies leveraging the Cell Shuttle as a platform for their processes.

“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," said Fabian Gerlinghaus, CEO and co-founder of Cellares. “This designation now gives cell therapy developers leveraging Cellares IDMO manufacturing services prioritized FDA review, which has the potential to shorten development times, making these therapies available to more patients faster.”

Cellares’ Cell Shuttle has performed automated, end-to-end, cell therapy manufacturing, including the processes of cell enrichment, cell selection, transduction, transfection, activation, expansion, and formulation while meeting all in-process and final product specifications of commercial cell therapies. This performance underscores the system's capacity to reliably produce high-quality therapeutic products at scale.

“The FDA’s AMT designation for the Cell Shuttle validates Cellares’ Quality-by-Design methodology and provides therapy developers an expedited regulatory pathway,” said Eric Fulmer, Vice President of Quality at Cellares. ”By automating cell therapy manufacturing on the Cell Shuttle, our clients will have a streamlined and cost-effective pathway from clinical development to commercial manufacture, ultimately accelerating patient access to these critical therapies."

With IDMO Smart Factories in development across the US, Europe, and Japan, Cellares offers clients global cell therapy manufacturing services to support early clinical development that also seamlessly scales to support industrial-scale manufacturing in the commercial setting, achieving economies of scale even at low production volumes.

For further details about the FDA's Advanced Manufacturing Technologies Designation Program, visit FDA AMT Guidance. Additional information on the Cell Shuttle technology is available at Cellares.

About Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle™ integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. While the Cell Shuttle automates cell therapy manufacturing, the Cell Q™ automates quality control both for in-process and release testing. Cell Shuttles and Cell Qs will be deployed in Cellares’ Smart Factories around the world, enabling each Smart Factory to produce 10 times as many cell therapy batches as a conventional CDMO with the same facility size and headcount. Partnering with Cellares enables early-stage cell therapy developers advantages of immediate, small-volume economies of scale as well as the ability to scale seamlessly to meet the total global patient demand for commercially approved therapies.

The company is headquartered in South San Francisco, California with its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. Cellares is building a global network of IDMO Smart Factories with additional facilities under construction in Europe and Japan. The company is backed by world-class investors and has raised over $355 million in financing.

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“This designation now gives cell therapy developers leveraging Cellares IDMO manufacturing services prioritized FDA review, which has the potential to shorten development times, making these therapies available to more patients faster.”