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Autolus Therapeutics to Evaluate Automated Manufacturing of AUCATZYL® (obe-cel) on the Cellares Cell Shuttle™ Platform
Globenewswire· 2026-01-06 14:00
Core Insights - Autolus Therapeutics is evaluating the feasibility of Cellares' Cell Shuttle platform to enhance its commercial manufacturing operations in the UK, aiming for a capital-efficient expansion of its manufacturing footprint due to expected future demand exceeding current capacity [1][6]. Company Overview - Autolus Therapeutics is a biopharmaceutical company focused on developing next-generation programmed T cell therapies for cancer and autoimmune diseases, with its marketed therapy AUCATZYL® (obe-cel) approved in multiple regions for treating relapsed or refractory B-cell precursor acute lymphoblastic leukemia [2][12]. - Cellares Corp is the first Integrated Development and Manufacturing Organization (IDMO) that provides global cell therapy development and manufacturing services, utilizing an Industry 4.0 approach to mass manufacture living drugs [7][9]. Technology and Manufacturing - Cellares' Cell Shuttle platform integrates all unit operations for CAR T manufacturing into a single-use, closed, pre-sterilized cartridge, capable of processing up to 16 patient batches in parallel, significantly increasing throughput compared to conventional facilities [3][4]. - The platform can deliver up to 10-fold higher throughput than traditional cell therapy manufacturing facilities while ensuring consistent batch quality and lower costs [4][8]. - Cellares' technology has received the FDA's Advanced Manufacturing Technology designation, providing partners with priority review mechanisms for regulatory submissions [5]. Market Potential - Autolus is exploring the use of obe-cel in additional indications beyond acute leukemia, including pediatric r/r B-ALL and autoimmune diseases, indicating a potential for significant market expansion [2][6]. - The collaboration with Cellares aims to address the industry's challenge of producing sufficient doses of CAR T therapies at sustainable costs, thereby meeting total patient demand [7].