Business
Cellares and Cabaletta Bio Successfully Complete Manufacturing Technology Adoption Program for Rese-cel Using the Cell Shuttle™ Platform
Technology Adoption Program (TAP) program success demonstrates the ability of Cellares’ IDMO Smart Factory to automate, lower costs and scale out
About this update from Cabaletta Bio, Inc.
[{"type":"text","content":"\nTechnology Adoption Program (TAP) program success 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 to treat patients with autoimmune diseases.\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nCellares, the first Integrated Development and Manufacturing Organization (IDMO), has concluded the Technology Adoption Program (TAP) on its automated cell therapy manufacturing Cell Shuttle™ for resecabtagene autoleucel, (rese-cel, previously known as CABA-201). Rese-cel is the lead clinical candidate in development by Cabaletta Bio, a biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. This successful collaboration facilitates the opportunity to engage in a clinical and commercial manufacturing relationship.\n\nCellares’ TAP assessed the feasibility of using Cellares' innovative 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. Cabaletta Bio and Cellares are now working towards the goal of manufacturing cGMP cell therapy batches to be delivered to patients. The Cellares network of global IDMO Smart Factories planned for the US, Europe, and Japan has the potential to provide Cabaletta Bio with the ability to automate, lower costs, and scale out manufacturing. Additionally, 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 U.S.), scleroderma (~90,000 patients in the U.S.) and lupus nephritis (~100,000 patients in the U.S.), in a fraction of the time and initial investment it would typically take to develop and deliver global supply for these large patient populations.\n\nCellares’ Cell Shuttle performed all unit operations in an automated manner, including cell isolation, enrichment, gene e...