Autolus will evaluate Cellares’ fully automated, high-throughput manufacturing platform in preparation for expansion into new indications
SOUTH SAN FRANCISCO, Calif. and LONDON, UK, January 6, 2026 – Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, and Cellares Corp, the first Integrated Development and Manufacturing Organization (IDMO), today announced that Autolus will assess the feasibility of Cellares’ Cell Shuttle platform to complement its commercial manufacturing operations at the Nucleus facility in Stevenage, UK.
Autolus commercializes AUCATZYL® (obecabtagene autoleucel; obe-cel), an autologous CD19 CAR T cell therapy approved in the United States, UK, and Europe for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). Obe-cel is also being studied in ongoing clinical trials to potentially expand its use in pediatric r/r B-ALL, and autoimmune diseases, such as lupus and multiple sclerosis.
Cellares’ Cell Shuttle platform integrates all unit operations for CAR T manufacturing into a single-use, closed, pre-sterilized cartridge operated on a fully automated platform capable of processing up to 16 patient batches in parallel.
This architecture enables a single IDMO Smart Factory to deliver up to 10-fold higher throughput than conventional cell therapy manufacturing facilities of similar footprint and headcount, while providing partners with more consistent batch quality, lower cost, and greater resilience in commercial supply. Cellares pairs the Cell Shuttle with Cell Q™, a purpose-built quality control platform for cell therapy drug products that transforms analytical testing from manual, fragmented workflows into automated, high-throughput methods with fully digital, compliant batch records.
The Cellares Cell Shuttle platform was the first to receive the FDA’s Advanced Manufacturing Technology (AMT) designation, which offers partners additional touchpoints and priority review mechanisms when referencing the platform in their INDs, BLAs, and post-approval supplements.
“We are evaluating obe-cel in a range of indications beyond acute leukemia, and if successful, expect future demand to exceed the manufacturing capacity at our Nucleus facility. Cellares’ Cell Shuttle platform may provide an attractive option for a capital-efficient expansion of our manufacturing footprint in the future,” said Christian Itin, PhD, Chief Executive Officer of Autolus.
“If a commercial CAR T shows durable benefit, the next question is whether the industry can produce enough doses at a sustainable cost,” said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. “Autolus has already built a strong manufacturing foundation. Our role is to extend that foundation with a global infrastructure that can reduce cost and process failure rates, while meeting total patient demand.”
About Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO), providing global cell therapy development and manufacturing services through an Industry 4.0 approach to the mass manufacture of the living drugs of the 21st century. The company enables biopharmaceutical partners to develop, scale, and commercialize cell therapies with the capacity, reliability, and economics required to meet total patient demand.
Cellares’ fully automated platforms – Cell Shuttle™ for end-to-end cell therapy manufacturing and Cell Q™ for automated in-process and release quality control – are deployed across its network of IDMO Smart Factories worldwide. These technologies deliver industry-leading manufacturing economics, higher process success rates, and the ability to produce up to 10× more cell therapy batches than conventional CDMOs with comparable footprint and headcount, resulting in the lowest cost of manufacturing in the industry.
Headquartered in South San Francisco, California, Cellares operates its first commercial-scale IDMO Smart Factory in Bridgewater, New Jersey, with additional facilities under construction in Europe and Japan. Through its global manufacturing network, Cellares is purpose-built to support both clinical and commercial programs and to expand access to life-saving cell therapies worldwide. For more information, visit www.cellares.com and follow Cellares on LinkedIn.
About AUCATZYL (obe-cel)
AUCATZYL® (obecabtagene autoleucel; obe-cel) is an autologous CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain and a fast target binding off-rate designed to reduce T-cell exhaustion while maintaining potent anti-leukemic activity. AUCATZYL is approved in the United States, European Union and United Kingdom for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, based on data from the FELIX study and related trials.
About Autolus Therapeutics plc
Autolus Therapeutics plc (Nasdaq: AUTL) is an early commercial-stage biopharmaceutical company focused on developing, manufacturing and delivering next-generation programmed T cell therapies for cancer and autoimmune disease. Using a broad, modular T cell programming toolkit, Autolus engineers targeted and controlled T cell therapies designed to recognize diseased cells, dismantle their defenses and eliminate them. Autolus has a marketed therapy, AUCATZYL® (obecabtagene autoleucel; obe-cel), and a pipeline of product candidates in development across hematologic malignancies, solid tumors and autoimmune conditions. For more information, please visit autolus.com.
For full indication, including important safety information, warnings and precautions, please visit https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-evaluate-automated-manufacturing-aucatzylr.
Cellares Contacts
Business Development:
bd@cellares.com
Investors:
ir@cellares.com
Media:
pr@cellares.com
Autolus Contact
Investors & Media:
Amanda Cray
