Terumo Blood and Cell Technologies has entered a new collaboration with Taiwan Bio Therapeutics to transition regulatory T‑cell manufacturing onto the automated Quantum Flex platform, marking a shift away from manual processes toward more scalable and repeatable production.
Taiwan Bio is developing the TregCel therapy TRK‑001, which is now in multicentre phase 2 trials assessing its potential to prevent graft rejection in kidney transplantation. Under the partnership, the companies will integrate Taiwan Bio’s existing phase 2 Treg manufacturing platform with Quantum Flex to create a next‑generation engineered Treg process.
The work builds on Terumo’s integrated 3‑in‑1 protocol that automates cell activation, viral transduction and cell expansion within a single closed bioreactor.
Wenyan Leong, Director, APAC Commercial Cell and Gene Therapy at Terumo BCT, said: “Manufacturing stability is the bridge between a scientific breakthrough and a viable therapy. By transitioning Taiwan Bio’s Treg programs onto Quantum Flex, we are replacing manual variability with an automated, standardised 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.”
Cyrus Yang, CEO of Taiwan Bio, explained: “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.”
The companies have begun evaluating the 3‑in‑1 workflow’s operational simplicity, efficiency and scalability, with initial transition and optimisation activities expected to conclude in the coming months.
Taiwan Bio will then use the integrated TRK‑001 process adapted to Quantum Flex as the basis for next‑generation engineered Treg programmes, with plans to advance at least one candidate to an Investigational New Drug application.
