LB47 - Making multiple therapeutic cell products from a cGMP-compliant iPSC line

Abstract

Induced pluripotent stem cell (iPSC) can differentiate into multiple phenotypes, and indeed multiple protocols for such differentiation have been established. Although the efficiency of different protocols is variable, most protocols work with most lines with some tweaking. To confirm this hypothesis and to make a clinically compliant line available for independent evaluation, we have taken the current Good Manufacture Practice (cGMP)-compliant iPSC line developed by the NIH, and used it to develop cellular products that are currently being considered for therapy. We focused on retinal cells, MSC, NSC, dopaminergic neurons and astrocytes. We obtained a WCB from the NIH and prepared a stock at passage 20. After testing quality we used it to generate multiple products using standard protocols. To confirm that these protocols could also be used for other iPSC lines we obtained a second clinically compliant line and tested the reproducibility of our methodology. Our results confirmed that the same protocols could be used with minimal modifications with multiple qualified lines. We believe that our demonstration that multiple products can be made from the same WCB bank and the same protocols can be used with multiple lines offers a path to a cost effective strategy for developing cellular products.