Cellares Announces Completion of First cGMP Cell Shuttle at IDMO Smart Factory in Bridgewater, New Jersey

September 05, 2024 at 08:00 AM EDT

Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and commercial-scale cell therapy manufacturing, announced today the commissioning of the first cGMP Cell Shuttle™ at the IDMO Smart Factory in Bridgewater, New Jersey. This marks an important milestone on the way to a fully fitted facility, which will be capable of producing up to 40,000 standard CAR-T cell therapy doses per year, or up to 100,000 doses of novel, two-day process CAR-T cell therapies.

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Cellares Cell Shuttle (Photo: Business Wire)

The Bridgewater, NJ IDMO Smart Factory is a clinical and commercial-scale cell therapy manufacturing innovation. The facility integrates advanced, end-to-end automation technologies including the Cell Shuttle and the Cell Q™. The Cell Shuttle automates cell therapy manufacturing, and the Cell Q automates quality control (both in-process QC and release testing). Interconnected software systems enable the auto-generation of electronic batch records, thereby reducing human labor as well as possibilities for operator error. Cellares’ partners will benefit from unprecedented scale, cost-efficiency, and speed with the highest standards of quality and safety.

Additional IDMO Smart Factories are planned for the U.S. and overseas. Together, these facilities will allow Cellares to meet its commitment to accelerate access to life-saving cell therapies by transforming manufacturing and enabling cell therapy developers to meet the total global patient demand for these products.

Cellares' CEO, Fabian Gerlinghaus, expressed his enthusiasm for this milestone, stating, "Bringing our first cGMP Cell Shuttle online in New Jersey is a major step for Cellares and our partners. This facility showcases our innovative approach and aligns with our mission to provide life-saving cell therapies to patients in need, faster and more efficiently than ever."

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 at high throughput, both for in-process and release QC. 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 academic medical centers, biotechnology companies, and pharmaceutical companies to accelerate cell therapy 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 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.

For more information about Cellares, please visit cellares.com.