Cellares, the first Integrated Development and Manufacturing Organization (IDMO), has achieved significant milestones in automating cell therapy manufacturing through strategic collaborations targeting both autoimmune diseases and cancer. The company's Cell Shuttle™ platform is demonstrating the potential to transform the production of advanced cellular therapies by addressing critical manufacturing bottlenecks.
Successful Automation of Autoimmune Disease CAR-T Manufacturing
Cellares has successfully completed its Technology Adoption Program (TAP) with Cabaletta Bio for resecabtagene autoleucel (rese-cel), a CD19-targeting CAR-T cell therapy designed to treat multiple autoimmune conditions. The collaboration demonstrated the Cell Shuttle platform's ability to automate and concurrently manufacture multiple rese-cel batches, meeting predefined quality requirements across all unit operations including cell isolation, enrichment, gene editing, activation, and expansion.
This achievement paves the way for a potential clinical and commercial manufacturing relationship between the companies. Cabaletta Bio, focused on developing curative targeted cell therapies for autoimmune diseases, could leverage Cellares' global network of IDMO Smart Factories planned for the US, Europe, and Japan to scale production significantly.
"The successful TAP program demonstrates the ability of Cellares' IDMO Smart Factory to automate, lower costs and scale out manufacturing for Cabaletta Bio's clinical-stage CAR T program," noted the companies in their announcement.
The partnership could be particularly impactful given the substantial patient populations that might benefit from rese-cel, including approximately 70,000 myositis patients, 90,000 scleroderma patients, and 100,000 lupus nephritis patients in the United States alone. Cellares' platform could potentially enable Cabaletta Bio to meet this global demand "in a fraction of the time and initial investment" typically required.
Accelerating Solid Tumor CAR-T Development
In a separate strategic collaboration, Cellares has partnered with the University of Wisconsin School of Medicine and Public Health to automate the manufacturing of a CRISPR-edited GD2 CAR-T investigational therapy targeting solid tumors.
This partnership aims to overcome manufacturing challenges that often hinder promising academic research from advancing to clinical trials. By providing access to clinical-scale manufacturing capabilities earlier in development, Cellares hopes to accelerate the transition from laboratory innovation to investigational therapy.
"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."
Industry 4.0 Approach to Cell Therapy Manufacturing
Cellares is pioneering an Industry 4.0 approach to cell therapy manufacturing with its integrated technology platform. The company claims its Cell Shuttle provides "true walk-away, end-to-end automation" for the entire manufacturing process, while its Cell Q™ system automates quality control at high throughput for both in-process and batch release testing.
According to Cellares, its IDMO Smart Factories can produce ten times as many cell therapy batches as conventional Contract Development and Manufacturing Organizations (CDMOs) with the same facility size and number of employees. The company also states its platform can deliver up to 50% lower batch prices compared to conventional CDMOs.
This manufacturing innovation addresses a critical industry challenge, as cell therapy production has been a significant bottleneck limiting patient access to these advanced treatments. By automating complex manufacturing processes and enabling simultaneous production of multiple therapies, Cellares aims to dramatically increase manufacturing capacity while reducing costs.
Global Expansion and Investment
Headquartered in South San Francisco, California, Cellares has established its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. The company has raised over $355 million in financing from investors to support its global expansion.
The company's approach appears particularly well-suited to address the manufacturing challenges faced by both early-stage academic developers and established biotechnology companies. By providing scalable manufacturing solutions from clinical development through commercial production, Cellares aims to eliminate the need for costly process redesigns and multiple technology transfers that typically slow the progress of cell therapies to market.
As cell therapies continue to demonstrate promising clinical results across multiple disease areas, Cellares' manufacturing innovations could play a crucial role in expanding patient access to these potentially transformative treatments.
