- Terumo BCT and Taiwan Bio will transition Taiwan Bio's Phase 2 Treg manufacturing onto Terumo's Quantum Flex 3‑in‑1 automated platform.
- Initial transition and optimization are planned to complete in the coming months to support TRK‑001 production and scale Treg manufacturing.
- The collaboration aims to enable next‑generation engineered Treg programs and advance at least one candidate to IND, building on a 2025 Cytotherapy 3‑in‑1 publication and the 2025 Nobel Prize recognition of Tregs.
Collaboration
Terumo Blood and Cell Technologies and Taiwan Bio Therapeutics are collaborating to migrate Taiwan Bio’s Phase 2 regulatory T‑cell (Treg) manufacturing for TRK‑001 onto Terumo’s Quantum Flex Cell Expansion System.
Technical approach
The project will adapt an integrated 3‑in‑1 automated workflow that combines cell activation, viral transduction and expansion in a single closed hollow‑fiber bioreactor to reduce manual handoffs and process variability, building on a 2025 Cytotherapy publication.
Objectives and timelines
Initial transition and optimization activities are planned to be completed in the coming months to support clinical‑scale production; objectives include improving manufacturability of Tregs, reducing cost of goods and cycle time, and establishing a standardized process for clinical and commercial scale.
Next steps
Taiwan Bio intends to use the adapted TRK‑001 process as a foundation for next‑generation engineered Treg programs with the goal of advancing at least one candidate to an IND application.
Context
The work leverages renewed interest in Tregs following the 2025 Nobel Prize recognition and addresses challenges inherent to rare, difficult‑to‑expand Treg populations.
