Terumo BCT, Steminent Join to Accelerate Late-Stage Clinical Manufacturing for Mesenchymal Stem Cell Therapies

Terumo Blood and Cell Technologies (Terumo BCT) is working with Steminent Biotherapeutics on acceleration of mesenchymal stem cell (MSC) therapies.

Specifically in this strategic collaboration, the companies want to ready Steminent for late-stage clinical manufacturing of its MSC-based therapy.

Steminent’s Reasons for MSC Development

By optimizing automated cell expansion for clinical development and future commercial production, the companies are addressing a key barrier. Too often, they say, the field of regenerative medicine is subject to roadblocks in clinical scale-up and commercialization. Variance in effectiveness in the transition from manual to automated manufacturing presents a major challenge to broad commercial availability.

Regulatory authorities have approved few MSC therapies, perhaps because of pitfalls like these. In addition to that, global adoption has been limited up to now.

How Terumo BCT Will Support

To remedy the issue, this collaboration leverages Terumo BCT’s Quantum Flex Automated Cell Expansion System, improving consistency, scalability, and efficiency. Terumo BCT will help develop a scalable production workflow designed to support process robustness as well as consistency between batches.

The design of the workflow aligns with Steminent’s goals. Terumo BCT will eventually transfer the workflow to Steminent for continued advancement.

“[This collaboration] allows us to strengthen our manufacturing foundation with processes designed for late-stage development,” said Steminent Chairperson Ling-Mei Wang. “This work supports our MSC clinical program’s next step, scaling for late-stage trials and eventual commercialization across multiple regions.”

Terumo’s Wenyan Leong, PhD, Director, APAC Commercial and Global Strategic Partnerships, contextualized Asia-Pacific region cell and gene therapy (CGT) progress.

“Terumo BCT is committed to supporting [CGT developers’] manufacturing strategy through our well-tested platforms and global expertise,” Leong said. “That means working alongside developers to design processes that hold up at scale—not just early development, but through late-stage.”

Steminent plans to expand usage of Quantum Flex upon successful completion of development milestones.