This week in Japan: iPS cell raw materials and culture tools

Four of the five recent Japanese stories we covered this week concern the materials and tools that iPS cell and MSC products are made with. Here they are, with what each one changes for companies that sell to Japan, make in Japan or partner with Japanese developers.

Ajinomoto's StemFit medium is in an approved iPS cell product

Ajinomoto said on October 16 that its StemFit AK03N medium is used to develop and manufacture RiHEART, Cuorips' iPS cell-derived cardiomyocyte sheet for severe heart failure caused by ischemic cardiomyopathy. RiHEART received conditional, time-limited approval in Japan in March 2026, and the first transplant after approval took place in September. Ajinomoto says it supports commercial and large-scale users through a Master File (MF) registered with PMDA, and that it is developing a new product for large-scale culture. For a supplier of a competing medium, the point is timing: in an allogeneic iPS cell product, the medium is chosen at the cell stock stage and becomes part of the approved process, so changing it later means showing the cells are unchanged. Ajinomoto's release (Japanese)

A clinical-grade reprogramming vector, with a date

TOKIWA Bio plans to supply its Stealth RNA Vector (SRV) for making iPS cells in clinical grade from the first quarter of 2027, Nikkei Biotech reported on October 14. The viral testing behind that grade will be done by TFBS Bioscience of Taiwan, under an alliance signed at BioJapan on October 8. The reprogramming vector is the first raw material an iPS cell line touches. A developer planning a line for 2027 or later can plan for clinical use from the first step instead of tracing a research-grade vector afterward. Our story

CellFiber starts selling Zeito in Japan and the US

CellFiber, a University of Tokyo spinout, began selling its Zeito cell fiber systems in Japan and the United States on October 8, after opening a US subsidiary in Philadelphia on October 1. The Zeito Plus is the GMP model, with a single-use kit and aseptic connectors to culture bags. The cells sit inside thin alginate gel tubes rather than on the outside of microcarriers, which should reduce shear, so shear-sensitive cells such as iPS cells and MSCs are the obvious candidates. The US unit plans to support onboarding and process development locally, but cell recovery and alginate quality control still have to be tested with each developer's own cells. Our story

PHC and Sekisui take MSC microcarrier culture to 1 L

PHC and Sekisui Chemical said on October 6 that MSCs grown on a Sekisui microcarrier still in development, in PHC's LiCellGrow automated culture device, kept their growth and quality at 1 L of medium. LiCellGrow measures glucose and lactate in line and changes the medium on those readings. Yields and culture times have not been published. Detailed results are due at the 26th Congress of the Japanese Society for Regenerative Medicine in March 2027. Our story

Spiber opens its fermentation plant to customers

Spiber, maker of Brewed Protein materials, launched SPIBER BIOFOUNDRY on October 2: contract strain development and fermentation from 1 L bench fermenters through 2,000 L vessels in Tsuruoka to commercial fermenters of more than 100 kL in Rayong, Thailand. It reports titers of 50 g/L for its own strains at commercial scale. The listed targets are reagents, enzymes, diagnostic raw materials and food ingredients. Drug substances are not on the list and the release does not mention GMP, so a pharmaceutical user would have to check the quality system first. Our story

Dates already set

The next fixed dates from these stories fall in 2027: TOKIWA Bio's clinical-grade SRV supply from the first quarter, and the PHC and Sekisui results at the Japanese Society for Regenerative Medicine congress in March.