2 hours ago
Terumo Blood and Cell Technologies has partnered with Taiwan Bio Therapeutics to transition regulatory T-cell (Treg) manufacturing onto the automated Quantum Flex platform, moving away from manual processes toward more scalable and consistent production.
Taiwan Bio is developing the TregCel therapy TRK-001, currently in multicenter phase 2 trials evaluating its potential to prevent graft rejection in kidney transplantation. Through this collaboration, the companies will integrate Taiwan Bio’s existing phase 2 Treg manufacturing platform with Quantum Flex to establish a next-generation engineered Treg process.
This effort builds on Terumo’s integrated 3-in-1 protocol, which automates cell activation, viral transduction, and cell expansion within a single closed bioreactor.
Wenyan Leong, Director of APAC Commercial Cell and Gene Therapy at Terumo BCT, stated: “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, 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.”
Cyrus Yang, CEO of Taiwan Bio, added: “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 cost of goods sold (COGS), and shorten cycle time – accelerating clinical translation across our Treg pipeline.”
The companies have begun assessing the 3-in-1 workflow’s operational simplicity, efficiency, and scalability, with initial transition and optimization activities expected to conclude in the coming months.
Following this, Taiwan Bio will use the integrated TRK-001 process adapted to Quantum Flex as the foundation for next-generation engineered Treg programs, with plans to advance at least one candidate to an Investigational New Drug application.
