Cellares, Cabaletta successfully demonstrate automated cell therapy manufacturing
Cellares announced that it has successfully completed a Technology Adoption Program (TAP) using its automated cell therapy manufacturing Cell Shuttle for Cabaletta Bio’s lead clinical candidate rese-cel, a CAR T-cell therapy designed to treat patients with a broad range of autoimmune diseases.
The TAP demonstrated 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,” according to the announcement.
Having successfully delivered automated, concurrent manufacture of multiple rese-cel batches on a single Cell Shuttle, the two companies are working towards the goal of manufacturing cGMP cell therapy batches to be delivered to patients.
“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,” Gwendolyn Binder, president of science and technology at Cabaletta Bio, said in a statement. “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.”
Cellares is deploying its Cell Shuttle, which automates cell therapy manufacturing, at the company’s integrated development and manufacturing organization (IDMO) “smart” factories. The first commercial scale smart factory is operational in Bridgewater, New Jersey, with other facilities under construction in Europe and Japan.
“We really turned the page from R&D to commercialization,” Fabian Gerlinghaus, co-founder and CEO of Cellares, told Pharma Manufacturing last month. “We now have commercial-ready, cGMP-compliant versions of the Cell Shuttle and the Cell Q for automated manufacturing and quality control.”
Cellares counts five Big Pharma companies among its customers — two of which, Bristol Myers Squibb (BMS) and Gilead’s Kite, have been publicly disclosed — as well as smaller biotech companies such as Caballeta Bio and Lyell Immunopharma.
The first U.S. commercial scale site for Cellares in Bridgewater will be capable of producing up to 40,000 standard CAR T-cell therapy doses annually, or up to 100,000 doses of novel, two-day process CAR T-cell therapies.
The Bridgewater facility has the capacity to accommodate 38 Cell Shuttles, while the sites in Europe and Japan will each house 48 Cell Shuttles. When all three facilities are up and running, Cellares estimates that it will produce up to 380,000 patient doses per year.
In August 2023, Cellares secured $255 million in Series C funding led by new investor Koch Disruptive Technologies with participation from BMS, bringing the total raised at that time by the company to more than $355 million. Gerlinghaus said Cellares is looking to add to its financing with $250 million in Series D funding.