The cGMP Cell Shuttle will be used to manufacture cell therapies for first clinical trials

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and commercial-scale cell therapy manufacturing, today announces the completion of its first current Good Manufacturing Practice (cGMP)-compliant Cell Shuttle™. The Cell Shuttle is an automated, ultra-high throughput, cell therapy manufacturing platform designed to meet global patient demand while reducing costs and process failure rates. The release of this new version of the Cell Shuttle platform is an important milestone on the way to ensuring clinical readiness by the end of 2024.

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First cGMP Cell Shuttle & Cellares co-founders Omar Kurdi (left) and Fabian Gerlinghaus (right). (Photo: Business Wire)

It is critical that cell therapies meet the highest standards of safety, efficacy, and consistency in a field where the quality of production directly impacts patient outcomes. cGMP compliance confirms that the Cell Shuttle has been built and controlled according to quality standards that meet strict regulatory requirements, assuring patient safety.

"The completion of our first cGMP-compliant Cell Shuttle instills confidence among healthcare providers, patients, and partners in the quality and reliability of the Cell Shuttle and signals our commitment to the highest standards of production," stated Fabian Gerlinghaus, CEO of Cellares. “By adhering to cGMP standards, Cellares ensures that cell therapies produced on the Cell Shuttle are safe, effective, and are consistently of the highest quality which is critical for patient care and therapeutic outcomes.”

The cell therapy sector faces notable challenges, including the inability of manual manufacturing processes to scale effectively, high costs, and high process failure rates. The cGMP-compliant Cell Shuttle by Cellares addresses these issues by offering an automated manufacturing solution designed to reduce labor and facility size required by 90%. As a result, Cellares’ IDMO Smart Factories can produce 10 times more cell therapy batches per year than conventional CDMO facilities, with the workforce and the same footprint.

The recent expansion with the new commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, underscores Cellares’ commitment to rapidly advance cell therapy manufacturing technologies. These advancements solidify Cellares' position as a pioneering manufacturing partner in the cell therapy industry, positioned to meet increasing manufacturing demands with its innovative manufacturing solutions.

For more information about Cellares’ cGMP Cell Shuttle, please visit cellares.com/technology

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 both 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. Cell Shuttles will be deployed in Cellares' Smart Factories around the world to meet global patient demand for cell therapies at commercial scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.

The company is headquartered in South San Francisco, California, with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

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