Innovation to Integration: The Translation of hPSC based cell therapies from Academic Research to Industry Standards

The trajectory from breakthrough discovery to scalable cell therapy can be as daunting as it is thrilling. While the cell therapy field is rapidly developing, early scientific research needs to be rapidly adapted and integrated into CMC development and subsequently commercial manufacturing. During the transfer of promising new therapies from academia researchers into pharmaceutical industry partners often face a huge conundrum: materials and technologies transfer from laboratory setting to manufacturer for clinical trials or marketing applications often are challenged by regulatory agencies based on their country or regional pharmaceutical regulations. However, this pathway is navigable with the right guidance. This chapter provides recommendations and discusses strategies on starting materials, raw materials, process development, and adequate documentation of early development activities aiming to aid researchers in refining and adapting the product development that meets with country or regional regulations and assures patient safety. This is needed not only to obtain early-stage regulatory approval but also to achieve consistent product quality and efficiency of the cell therapy and set the stage for the transition into late-stage development and manufacturing.