Taiwan Bio Partners with Terumo to Automate Regulatory T-Cell Manufacturing for Transplant Therapy
核心洞察
Taiwan Bio Therapeutics (搜索) has partnered with Terumo Blood and Cell Technologies to transition regulatory T-cell (搜索) manufacturing from manual processes to the automated Quantum Flex platform for improved scalability and repeatability.
The collaboration focuses on Taiwan Bio's TRK-001 therapy, currently in multicenter Phase 2 trials for preventing graft rejection (搜索) in kidney transplantation (搜索) patients.
The partnership will integrate Terumo's 3-in-1 automated protocol that combines cell activation, viral transduction, and expansion within a single closed bioreactor system.
Taiwan Bio Therapeutics (搜索) has entered into a strategic collaboration with Terumo Blood and Cell Technologies to transition regulatory T-cell (搜索) (Treg) manufacturing from manual processes to the automated Quantum Flex platform, addressing critical manufacturing challenges for these inherently unstable cell types. The partnership aims to establish a more scalable and repeatable production process for Taiwan Bio's TregCel (搜索) therapy TRK-001, which is currently in multicenter Phase 2 trials evaluating its potential to prevent graft rejection (搜索) in kidney transplantation (搜索).
Addressing Manufacturing Challenges for Sensitive Cell Types
The collaboration leverages the 2025 Nobel Prize-winning discovery of Tregs, which regulate immune tolerance, to develop more robust manufacturing processes. As 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 partnership will integrate Taiwan Bio's existing Phase 2 Treg manufacturing platform with Terumo's Quantum Flex system to create a next-generation engineered Treg process. This transition represents a significant shift from manual variability toward standardized automation designed to perform at both clinical and commercial scale.
Automated 3-in-1 Manufacturing Protocol
The collaboration builds on Terumo's integrated 3-in-1 protocol, published in Cytotherapy, which automates cell activation, viral transduction, and cell expansion within a single closed bioreactor. This approach reduces manual handoffs and process variability, addressing key challenges in Treg manufacturing.
Wenyan Leong, Director, APAC Commercial Cell and Gene Therapy at Terumo BCT, emphasized the importance of manufacturing stability: "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."
Implementation Timeline and Future Applications
The companies have begun evaluating 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. Initial transition and optimization activities are expected to conclude in the coming months.
Following successful integration, Taiwan Bio will use the automated TRK-001 process adapted to Quantum Flex as the foundation for next-generation engineered Treg programs. The company plans to advance at least one next-generation Treg candidate to an Investigational New Drug (IND) application, while both companies plan to pursue joint industry engagement activities in the region.
This collaboration represents a significant step forward in addressing the manufacturing challenges associated with regulatory T-cell (搜索) therapies, potentially improving accessibility and reducing production costs for these promising immunomodulatory treatments.