Quality Control of iPSC-derived clinical products

Quality Control of iPSC-derived clinical products

Shin Kawamata, MD, PhD, Director of the R&D Center for Cell Therapy at the FBRI (Kobe, Japan) stresses the importance of controlling the quality of iPSC banks at a very early stage, including CiRA cell lines, to meet safety guidelines at clinical stages.

There’s been a recent paper from Shinya Yamanaka encapsulating the challenges for the clinical application of iPS cell derived products. I know that you are looking very closely at that. What’s your take on how to mitigate these risks of quality, of purity, of immunogenicity ?

 

I am working for the CiRA, especially on a Quality Control (QC) project. The CiRA produces iPS cells, but they did not know the quality of their cells and their outcome. The CiRA does not have good information on about what the final product is like.
Researchers get iPS cells from CiRA but they don’t know the quality of the iPS cell line.

Therefore, at the FBRI, we are an institution that impartially checks cell quality through all-genome sequencing and mouse studies (it takes about one and a half year).

We make reports and we summon people involved in this project to share information so that we can better understand the quality of iPS cells.

With the QC project, our goal is to help the CiRA to improve their quality.