• Taiwan Bio will leverage the Quantum Flex™ Cell Expansion System 3-in-1 workflow beyond CAR-T to support development of regulatory T-cell therapies 

• Program will evaluate simplified, scalable, automated manufacturing aligned with late-stage development and clinical readiness needs 

Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company and global leader in blood management solutions, has entered into a collaboration with Taiwan Bio Therapeutics Inc. (Taiwan Bio) to transition regulatory T-cell (Treg) manufacturing onto the automated Quantum Flex platform, supporting a move from manual processes toward more scalable, repeatable production. 

Taiwan Bio is leveraging the 2025 Nobel Prize-winning discovery of Tregs, which regulate immune tolerance, for the development of the TregCel therapy TRK-001, now in multicenter Phase 2 trials to test its ability to prevent graft rejection in kidney transplantation. Through the new collaboration, the parties will integrate Taiwan Bio’s existing Phase 2 Treg manufacturing platform with Quantum Flex to develop a new process for next-generation engineered Treg manufacturing. The work will build on Terumo BCT’s integrated 3-in-1 protocol, published last year in Cytotherapy,i which automates cell activation, viral transduction and cell expansion within a single closed bioreactor, reducing manual handoffs and process variability. 

"Manufacturing stability is the bridge between a scientific breakthrough and a viable therapy,” said Wenyan Leong, Director, APAC Commercial Cell and Gene Therapy, Terumo BCT. “By transitioning Taiwan Bio’s Treg programs onto Quantum Flex, we are replacing manual variability with an automated, standardized process designed to perform at both clinical and commercial scale. This collaboration is about establishing a robust operational foundation that allows developers to advance even the most sensitive cell types with confidence." 

"As a rare, difficult-to-expand, and inherently unstable cell type, Tregs make manufacturability a defining consideration. Our collaboration with Terumo BCT enables us to move beyond a highly manual workflow and evaluate an integrated, closed manufacturing approach that can improve efficiency and accessibility, reduce COGS [cost of goods sold], and shorten cycle time — accelerating clinical translation across our Treg pipeline,” said Cyrus Yang, CEO of Taiwan Bio.  

The companies have begun to evaluate the 3-in-1 workflow’s operational simplicity, manufacturing efficiency and scalability as part of Taiwan Bio’s evolving clinical manufacturing strategy for Treg therapies, planning to complete initial transition and optimization activities in the coming months.  

Taiwan Bio will then use the integrated TRK-001 process adapted to Quantum Flex as a foundation to enable next-generation engineered Treg programs, with the goal of advancing at least one next-generation Treg candidate to an Investigational New Drug (IND) application, while the companies plan to pursue joint industry engagement activities in the region.