Cellares, an Integrated Development and Manufacturing Organization (IDMO), concluded the Technology Adoption Program (TAP) on its automated cell therapy manufacturing Cell Shuttle™ for resecabtagene autoleucel, (rese-cel, previously known as CABA-201).
Cellares’ TAP assessed the feasibility of using the Cell Shuttle platform to automate the manufacturing of Cabaletta’s rese-cel drug product, a CD19-targeting CAR T cell therapy designed to treat patients with a broad range of autoimmune diseases. The TAP successfully delivered automated, concurrent manufacture of multiple rese-cel batches on a single Cell Shuttle, according to Cellares.
Cabaletta Bio and Cellares are now working toward manufacturing cGMP cell therapy batches to be delivered to patients. The Cellares network of global IDMO Smart Factories planned for the United States, Europe, and Japan has the potential to provide Cabaletta Bio with the ability to automate, lower costs, and scale out manufacturing, according to Fabian Gerlinghaus, CEO of Cellares.
Facilitating global expansion
Additionally, Gerlinghaus said, this partnership may facilitate global expansion of rese-cel via rapid technology transfer to additional IDMO Smart Factories. This has the potential to allow Cabaletta Bio to achieve the global scale required to meet the total patient demand across multiple autoimmune diseases, including myositis (~70,000 patients in the United States), scleroderma (~90,000 patients in the United States), and lupus nephritis (~100,000 patients in the United States), in a fraction of the time and initial investment it would typically take to develop and deliver global supply for these large patient populations, continued Gerlinghaus.
“Through our partnership with Cellares, our teams have successfully achieved proof of concept for the ability to automate the rese-cel cellular drug substance manufacturing process,” said Gwendolyn Binder, president, science and technology at Cabaletta Bio. “We look forward to continuing our work together to complete activities required to enable use of the Cell Shuttle in clinical trials to support the delivery of these potentially curative autologous therapies to more patients with autoimmune diseases.”
“The success of this Technology Adoption Program (TAP) demonstrates the effectiveness of the Cell Shuttle as a scalable, automated, and cost-effective platform for the manufacturing of cell therapies. Working with Cabaletta Bio proves that small biotech companies can successfully partner with Cellares to benefit from next-generation automation,” noted Gerlinghaus.