• Strategic collaboration aims to facilitate the manufacturing of UW–Madison’s internally developed CAR-T investigational therapy
• Partnership seeks to address cell therapy manufacturing bottlenecks and accelerate development towards clinical trials
• Clinical scale manufacturing of cell therapy assets provides latest validation of Cell Shuttle’s ability to empower partners to seamlessly scale production

Cellares, the pioneering Integrated Development and Manufacturing Organization (IDMO), has announced a strategic collaboration with the University of Wisconsin School of Medicine and Public Health to automate the manufacturing of a CRISPR-edited GD2 CAR-T investigational therapy.

Cellares’ Cell Shuttle™ supports early-phase biotechnology and academic cell therapy developers by providing an integrated, automated solution enabling immediate economies of scale and up to 50% lower batch prices compared to conventional CDMOs. As cell therapy assets mature, the platform ensures a seamless transition from clinical development to commercial-scale manufacturing, eliminating the need for costly process redesigns and multiple technology transfers and accelerating time-to-market for innovative therapies.

The collaboration highlights Cellares’ commitment to empowering principal investigators and researchers in academic institutions by providing access to an automated, reproducible, and scalable manufacturing platform at the earliest stages of clinical development. By leveraging the Cell Shuttle’s ability to simultaneously manufacture multiple cell therapy products in parallel, this partnership overcomes longstanding manufacturing bottlenecks caused by limited manufacturing capacity.

This approach shortens the journey from proof-of-concept in the lab to an investigational therapy suitable for clinical trials, ultimately aiming to improve care for patients with solid tumors. It also demonstrates how the Cell Shuttle is an automated solution for cell therapy developers of all stages, allowing them to seamlessly scale up as their manufacturing needs evolve.

“Solid tumors can be challenging to treat, and many patients have limited therapeutic options,” said Fabian Gerlinghaus, Co-founder and CEO of Cellares. “By collaborating with researchers at the University of Wisconsin–Madison on their CRISPR-edited GD2 CAR-T product, we remove the manufacturing barriers that can hinder promising research. Our Cell Shuttle automates and scales production to a clinical level, which accelerates the transition from academic innovation to investigational therapy and brings hope to those who need new treatment options.”

By enabling the CRISPR-edited GD2 CAR-T project at University of Wisconsin–Madison to achieve clinical-scale manufacturing earlier, the partnership can help unlock potential investment into the experimental therapy and expedite its path to initial human trials. The Cell Shuttle automates key steps that traditionally slow down development, thus enabling life-saving discoveries to advance more quickly.

Cellares encourages collaboration with researchers, academic institutions, and commercial partners at all stages of their projects, demonstrating its unwavering commitment to advancing the field of cell therapy and expanding patient access to next-generation treatments. For more information on the Cell Shuttle and Cellares’ scalable manufacturing solutions, please visit cellares.com.

About University of Wisconsin School of Medicine and Public Health

The University of Wisconsin School of Medicine and Public Health is recognized as one of the nation’s leading institutions in health sciences education, research, and service. Founded in 1907 as the medical school of the University of Wisconsin–Madison, in 2005 it became the nation’s first school to integrate the disciplines of medicine and public health. With a deep commitment to a vision of healthy people and healthy communities, we translate discovery into application and interconnect clinical care, education and research. The school employs more than 5,400 faculty and staff and provides educational opportunities for nearly 2,400 students and postgraduate trainees. Grants awarded to School of Medicine and Public Health principal investigators in fiscal year 2023 totaled $641 million in federal and non-federal awards. Some of the nation’s leading researchers, educators, and clinicians are among the faculty, including several National Medal of Science recipients and National Academy of Science honorees. For more information, visit med.wisc.edu.

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 batch release QC, addressing both manufacturing and QC bottlenecks. Cell Shuttles and Cell Qs will be deployed in Cellares’ IDMO Smart Factories around the world, enabling each Smart Factory to produce 10 times as many cell therapy batches as conventional CDMOs with the same facility size and number of employees. Partnering with Cellares enables academic medical centers, biotechnology companies, and pharmaceutical companies to accelerate cell therapy development, 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.

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By collaborating with researchers at the University of Wisconsin–Madison on their CRISPR-edited GD2 CAR-T product, we remove the manufacturing barriers that can hinder promising research.