Pharmaceutica Analytica Acta

Abstract

Accelerating Progress in Regenerative Medicine by Advancing Distributed Stem Cell-based Normal Human Cell Biomanufacturing

James L Sherley

Successful new industries are forged in the gap between early-stage technological innovation and unmet technological needs that block new avenues to improving the quality of human life. This principle applies quite aptly to the envisioned industry of normal human cell biomanufacturing. The highly anticipated benefits of regenerative medicine have been delayed by such a technological gap. In all its varied formulations, regenerative medicine has one essential requirement, an adequate supply of normal human tissue cells for therapeutic interventions ranging from repairing debilitating injuries to treating diseases caused by tissue cell defects and deficiencies. However, with a few recent exceptions, the primary source of cells for existing and emerging regenerative therapies is direct harvest of therapeutic tissue cells from normal donors, either living or deceased. Cell supply based on donation is inherently scarce and unreliable. On-demand production of normal human tissue cells is now recognized as the ratelimiting unmet technological need that stands in the way of progress in regenerative medicine. Three different types of tissue stem cells, distributed (also known as adult), embryonic, and induced pluripotent, have been suggested as the solution for normal human tissue cell biomanufacturing. However, with currently available cell biotechnologies, only distributed stem cells (DSCs) present a realistic solution. Herein, the suitability of DSCs for advancing a new industry of normal human cell biomanufacturing is considered with respect to their pluripotent counterparts, human embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).