Xianmin Zeng
Buck Institute, Novato, CA, USA
Title: Making multiple therapeutic cell products from a cGMP-compliant iPSC lin
Biography
Biography: Xianmin Zeng
Abstract
We have developed several current Good Manufacture Practice (cGMP)-compliant induced pluripotent stem cell (iPSC) lines for clinical applications. Here we show that multiple cellular products currently being considered for therapy can be generated from a single master cell bank of a clinically compliant iPSC line. Here we tested differentiation into therapeutic relevant cell types of the three germ layers by standardized protocols using a stock prepared from the cGMP-compliant working cell bank. Cells we generated include 1) neural stem cells, dopaminergic neurons and astrocytes, 2) retinal cells (RPE and photoreceptors) and 3) hepatocyte, endothelial and mesenchymal cells. To confirm that these protocols can also be used for other iPSC lines we tested the reproducibility of our methodology with a second clinically compliant line. Our results confirmed that the same protocols could be used with minimal modifications with multiple qualified lines. In addition, we introduced a constitutively expressed GFP cassette in Chr13 safe harbor site and observed no significant difference in growth and differentiation between the engineered line and the control line. We believe that our demonstration that multiple products can be made from the same WCB, and that the same protocols can be used with multiple lines offers a path to a cost effective strategy for developing cellular products from iPSC lines.