Cellares announced that Cabaletta Bio has infused the first two patients with its investigational CAR T cell therapy rese-cel using drug product manufactured on Cellares’ automated Cell Shuttle platform.
The achievement marks an important step for Cellares’ Integrated Development and Manufacturing Organization (IDMO), model, which is designed to support scalable manufacturing of autologous cell therapies with lower capital investment and reduced cost of goods. The autologous cell therapy met all release criteria and was manufactured using Cellares’ automated manufacturing platform.
Autologous CAR T cell therapies have shown clinical benefits in oncology, but their broader use has been limited by high manufacturing costs, limited scalability, process inconsistency, and operational complexity tied to traditional manual manufacturing. Cellares’ Cell Shuttle and Cell Q systems are intended to give biotechnology and pharmaceutical companies access to scalable production capacity without requiring large upfront infrastructure investments.
Cabaletta began working with Cellares in 2023 after identifying the company’s automated and industrialized manufacturing approach as a potential solution to the cost and scale barriers associated with autologous CAR T production. Over the past three years, the companies collaborated to adapt the rese-cel manufacturing process to the Cell Shuttle platform and generated comparability data across multiple process development and engineering runs. The automated process was benchmarked against Cabaletta’s established manufacturing process.
That dataset supported the submission and FDA clearance of an Investigational New Drug amendment allowing the Cell Shuttle platform to be used for clinical manufacturing of rese-cel.
“This milestone is a transformative moment for the field of autologous cell therapy,” said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. “For years, the promise of autologous CAR T has been constrained by manufacturing models that were never designed to scale. The successful dosing of patients with rese-cel manufactured on the Cell Shuttle demonstrates that automation can deliver GMP drug products on time and within specification. This system can deliver autologous cell therapies at a scale and cost structure that makes these therapies accessible for much larger patient populations.”
