Autolus evaluates Cellares automated CAR-T manufacturing platform
Autolus Therapeutics, a commercial-stage biopharma company developing and manufacturing programmed T cell therapies, said it is assessing the feasibility of Cellares’ automated CAR-T manufacturing platform to complement commercial operations at its Nucleus facility in Stevenage, United Kingdom.
The company said it will evaluate the Cellares Cell Shuttle platform, a fully automated, closed, single-use manufacturing system, as a potential option to support future capacity needs. According to the companies, the assessment aims to determine whether the platform can facilitate a capital-efficient expansion of Autolus’ manufacturing footprint if demand exceeds current capacity.
Autolus is commercializing an autologous CD19 CAR-T therapy approved in the United States, the United Kingdom, and Europe for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia, according to the company. The therapy is also being studied in clinical trials for additional indications, including pediatric leukemia and autoimmune diseases such as lupus and multiple sclerosis.
Cellares said its Cell Shuttle platform integrates all CAR-T unit operations into a single pre-sterilized cartridge operated on an automated system capable of processing up to 16 patient batches in parallel. The company said the architecture can deliver significantly higher throughput than conventional cell therapy facilities with comparable footprint and staffing, while improving batch consistency and supply resilience.
The platform has received the U.S. Food and Drug Administration’s Advanced Manufacturing Technology designation, which the company said provides additional regulatory interaction opportunities when referenced in development and commercial filings.
“If successful, we expect future demand to exceed the manufacturing capacity at our Nucleus facility,” Autolus CEO Christian Itin said in a statement, adding that the platform could support future expansion.
Cellares CEO Fabian Gerlinghaus added that the collaboration is intended to address cost, scale and reliability challenges associated with commercial CAR-T manufacturing.
