Terumo Blood and Cell Technologies (Terumo BCT) has entered into a strategic collaboration with Taiwan Bio Therapeutics Inc. to advance the manufacturing of regulatory T-cell (Treg) therapies, marking a significant step toward scalable and standardized cell therapy production. The partnership aims to transition Taiwan Bio’s existing Treg manufacturing processes onto Terumo BCT’s automated Quantum Flex platform, replacing labor-intensive manual workflows with a more efficient, closed-system approach.
Treg cells, which play a crucial role in maintaining immune tolerance, have gained increasing attention in recent years for their therapeutic potential in autoimmune diseases and transplantation. Taiwan Bio is leveraging this science in the development of its lead therapy, TRK-001, which is currently being evaluated in multicenter Phase 2 clinical trials for the prevention of graft rejection in kidney transplant patients.
Through the collaboration, the two companies will integrate Taiwan Bio’s current Phase 2 manufacturing process with Quantum Flex, enabling a next-generation approach to engineered Treg production. The effort builds on Terumo BCT’s previously developed “3-in-1” protocol, which consolidates key steps—cell activation, viral transduction, and cell expansion—within a single automated bioreactor. This integrated system is designed to reduce variability, minimize manual intervention, and improve reproducibility across manufacturing batches.
Industry experts note that manufacturing remains one of the biggest challenges in cell therapy development, particularly for Tregs, which are difficult to expand and inherently unstable. By introducing automation and closed-system processing, the collaboration aims to address these challenges while supporting both clinical and potential commercial-scale production.
Wenyan Leong, Director of APAC Commercial Cell and Gene Therapy at Terumo BCT, emphasized that consistent manufacturing processes are critical for translating scientific breakthroughs into viable therapies. She noted that the Quantum Flex platform is designed to provide a robust operational foundation capable of supporting sensitive cell types like Tregs.
Taiwan Bio CEO Cyrus Yang highlighted the importance of improving manufacturability for Treg-based therapies, stating that the collaboration will help reduce production costs, shorten manufacturing timelines, and enhance accessibility for patients. He added that transitioning away from manual processes is essential for advancing the company’s broader Treg pipeline.
The companies have already begun evaluating the operational efficiency and scalability of the integrated workflow, with initial optimization activities expected to be completed in the coming months. Looking ahead, Taiwan Bio plans to use the adapted process as a foundation for next-generation engineered Treg therapies, with the goal of advancing at least one candidate toward an Investigational New Drug (IND) application.
In addition to technical development, Terumo BCT and Taiwan Bio intend to engage with industry stakeholders across the Asia-Pacific region to promote innovation in cell therapy manufacturing. The collaboration underscores a broader industry trend toward automation and standardization, as developers seek to overcome production bottlenecks and bring advanced therapies to patients more efficiently.