Terumo Blood and Cell Technologies has reported what it described as a first demonstration of automated, end-to-end TCR-T manufacturing on a single small bioreactor in a collaboration with the University of Chicago.

The work shows that activation, transduction and expansion can be completed on the Quantum Flex Cell Expansion System without transferring material across multiple devices, aiming to address process fragmentation that is common across autologous T cell therapy workflows.

Researchers at the University of Chicago activated 10 million peripheral blood mononuclear cells, transduced them with a gamma retroviral vector and expanded them on the same system to up to 9 billion cells in 10 days. According to the team, the run maintained high viability throughout. Terumo said the results underscore the platform’s suitability for reproducible workflows across development and commercial settings.

Richard Koya, professor of medicine and director of cGMP vector development and production at the University of Chicago’s Cancer Center, said: “The ability to automate TCR-T cell processing end-to-end on a single bioreactor is a foundational advance in the evolution of cell therapy manufacturing.”

Thinle Chodon, co-director of the Cellular and Tissue Based Processing cGMP Core Facility at the University of Chicago and co-investigator on the study, added: “It opens the door to faster, more consistent manufacturing for therapies that could benefit patients with solid tumors and other hard-to-treat diseases.”

Mindy Miller, head of scientific development for cell therapy at Terumo BCT, said: “With Quantum Flex, we are building on our proven 3-in-1 CAR-T protocol to show the platform’s flexibility and applicability across multiple T cell modalities. Industry analysts, including the Alliance for Regenerative Medicine, note that developers are prioritising proven, adaptable platforms that can support multiple cell types and scales, like the Quantum Flex.”

Terumo previously published results in Cytotherapy showing a similar 3-in-1 CAR-T process developed with Eureka Biotechnology. The company said this new work demonstrates that the same integrated approach can also be applied to TCR-T, expanding the relevance of automated workflows as developers look toward scale-out strategies.

The Alliance for Regenerative Medicine reports that more than 2,000 cell and gene therapy trials are active globally, with manufacturing complexity frequently cited as a barrier to patient access. Automation, closed systems and process consolidation are increasingly viewed as central to reducing variability. Terumo said that the wider environment, including the FDA’s recent removal of some risk evaluation and mitigation strategies requirements for CAR-T therapies, has highlighted the need for scalable manufacturing processes that can support broader delivery.

The full dataset will be presented by Koya at the Advanced Therapies 2025 conference in Philadelphia.