Autolus Therapeutics to Explore Advanced Manufacturing of AUCATZYL® with Cellares' Cutting-Edge Technology
SOUTH SAN FRANCISCO, Calif. and LONDON, Jan. 06, 2026 — Autolus Therapeutics plc (Nasdaq: AUTL), a leading biopharmaceutical company focused on developing next-generation programmed T cell therapies, has announced a pivotal collaboration with Cellares Corp, a pioneering Integrated Development and Manufacturing Organization (IDMO). This partnership will explore the feasibility of Cellares’ innovative Cell Shuttle platform to enhance Autolus' commercial manufacturing operations at its Nucleus facility located in Stevenage, UK.
Autolus and AUCATZYL®: Background Information
Autolus Therapeutics is known for commercializing AUCATZYL® (obecabtagene autoleucel; obe-cel), a CD19-directed CAR T cell therapy that has gained approval in the United States, UK, and Europe for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). Currently, the company is also evaluating the potential applications of obe-cel in pediatric r/r B-ALL and various autoimmune diseases, including lupus and multiple sclerosis.
Innovative Manufacturing with Cellares' Cell Shuttle Platform
Cellares’ Cell Shuttle platform integrates all unit operations for CAR T manufacturing into a single-use, closed, pre-sterilized cartridge. This fully automated solution enables the processing of up to 16 patient batches simultaneously, significantly enhancing workflow efficiency. Notably, it can achieve up to a 10-fold increase in throughput compared to conventional CAR T manufacturing facilities of similar size and workforce. This transformation promises partners not only greater reliability in batch quality but also reduced costs and improved supply chain resilience.
Quality Control and Regulatory Compliance
The Cell Shuttle platform is complemented by Cell Q™, a specialized quality control platform that automates in-process testing and release protocols. This integration results in high-throughput, compliant digital batch records, improving overall manufacturing reliability. Remarkably, the Cell Shuttle was the first technology to secure the FDA’s Advanced Manufacturing Technology (AMT) designation, expediting regulatory processes for its users.
Implications for Autolus Therapeutics
Christian Itin, PhD, Chief Executive Officer of Autolus, commented, “As we evaluate obe-cel across various indications, we anticipate future demand may outstrip the manufacturing capacity of our Nucleus facility. The partnership with Cellares to leverage the Cell Shuttle platform represents a strategic opportunity for cost-effective expansion of our manufacturing capabilities.”
Fabian Gerlinghaus, Co-founder and CEO of Cellares, added, “Proving a commercial CAR T with sustained efficacy raises the key question of whether the industry can adequately meet patient demand at a sustainable cost. Autolus has established a strong manufacturing base, and our mission is to extend that foundation with a global infrastructure capable of minimizing costs and process failures.”
About Cellares Corp
Cellares is a groundbreaking IDMO focused on cell therapy development and manufacturing services. Utilizing an Industry 4.0 approach, Cellares positions itself as a leader in mass production of cell therapies, ensuring partners can meet global patient needs with reliability and economic efficiency. Its smart factories, equipped with fully automated systems like Cell Shuttle™ and Cell Q™, allow for the production of up to 10 times more cell therapy batches than traditional methods, resulting in highly competitive manufacturing costs.
Further Information on AUCATZYL®
AUCATZYL® is an autologous CD19-directed CAR T cell therapy that features a 4-1BB costimulatory domain and is designed to minimize T-cell exhaustion while preserving effective anti-leukemic activity. It is currently approved for adult patients with relapsed or refractory B-ALL based on promising data from the ongoing FELIX study and related trials.
About Autolus Therapeutics plc
Autolus Therapeutics plc (Nasdaq: AUTL) is an emerging commercial-stage biopharmaceutical company specializing in advanced T cell therapies for cancer and autoimmune diseases. Leveraging a versatile T cell programming toolkit, Autolus develops therapies designed to recognize and eliminate diseased cells effectively. With a market-approved therapy, AUCATZYL®, and a robust pipeline targeting hematologic malignancies, solid tumors, and autoimmune conditions, Autolus aims to revolutionize treatment options. For more details, visit autolus.com.