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Adoption Program for Complete Manufacturing Technology in Cellares and Cabaletta Bio


Cellares, an Integrated Development and Manufacturing Organization (IDMO), has successfully completed the Technology Adoption Program (TAP) for its automated cell therapy manufacturing platform, the Cell Shuttle™, specifically for Cabaletta Bio’s resecabtagene autoleucel (rese-cel). The TAP demonstrated the feasibility of automating the manufacturing of Cabaletta’s rese-cel drug product, a CAR T cell therapy designed to treat autoimmune diseases.

Following the successful completion of the TAP, Cellares and Cabaletta Bio are now collaborating to manufacture cGMP cell therapy batches for patient delivery. The partnership aims to leverage Cellares’ global network of IDMO Smart Factories to automate and scale out manufacturing, ultimately lowering costs and increasing efficiency.

Fabian Gerlinghaus, CEO of Cellares, highlighted that this partnership has the potential to facilitate the global expansion of rese-cel by enabling rapid technology transfer to additional IDMO Smart Factories. This could significantly reduce the time and investment required to meet the global demand for these therapies across various autoimmune diseases.

Gwendolyn Binder, president of science and technology at Cabaletta Bio, expressed excitement about the successful automation of the rese-cel manufacturing process and the potential to deliver these therapies to more patients with autoimmune diseases. The collaboration between Cellares and Cabaletta Bio demonstrates the effectiveness of the Cell Shuttle as a scalable and cost-effective platform for manufacturing cell therapies.

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