Cellares and Cabaletta Bio Advance Automated Cell Therapy Manufacturing

• Cellares has completed the Technology Adoption Program (TAP) for automating the manufacture of rese-cel, a CD19-targeting CAR T cell therapy developed by Cabaletta Bio.

• The successful collaboration paves the way for a potential clinical and commercial manufacturing partnership, leveraging Cellares’ IDMO Smart Factories for scalability and cost reduction.

Cellares, the first Integrated Development and Manufacturing Organization (IDMO), has concluded its Technology Adoption Program (TAP) for rese-cel, a CD19-targeting CAR T cell therapy developed by Cabaletta Bio. The program evaluated the feasibility of automating rese-cel’s manufacturing using Cellares’ Cell Shuttle™ platform, a next-generation automated system for cell therapy production.

The TAP successfully demonstrated the concurrent, automated manufacture of multiple rese-cel batches on a single Cell Shuttle. Following this milestone, Cellares and Cabaletta Bio are working towards cGMP manufacturing of clinical cell therapy batches. The Cellares IDMO Smart Factories, planned for the US, Europe, and Japan, could provide Cabaletta Bio with automation, cost efficiency, and scalable manufacturing capacity to meet global demand for rese-cel across multiple autoimmune diseases.

Rese-cel is being developed for the treatment of autoimmune diseases, including myositis, scleroderma, and lupus nephritis, which together affect more than 250,000 patients in the US. The partnership with Cellares may enable rapid technology transfer to additional IDMO Smart Factories, supporting a potential global rollout of the therapy while reducing time and investment required for large-scale supply.

During the program, Cellares’ Cell Shuttle performed key cell therapy manufacturing steps in an automated manner, including cell isolation, enrichment, gene editing, activation, and expansion. The resulting drug products met predefined quality requirements, demonstrating the platform’s ability to deliver high-quality cell therapies at scale.

“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.”

The Cellares IDMO Smart Factories are designed to allow biotech companies to scale manufacturing capacity seamlessly, from early clinical development through to commercial production. This could enable Cabaletta Bio to efficiently meet growing global demand for rese-cel while optimising costs and production timelines.