Pluripotent stem cells for drug development and therapy: bioprocess development challenges

Abstract

Human pluripotent Stem Cells (hPSC) have an enormous potential as a source for cell replacement therapies, tissue engineering, and in vitro toxicology applications. The lack of standardized and robust bioprocesses for their expansion and analytical tools for their characterization has hindered the application of PSC in clinical settings and as alternative cell sources for in vitro cell models used in pre-clinical research.

3D cell culture strategies for the production of hPSC exploiting the potential of scalable bioreactor technology will be discussed together with the application of -omic tools for characterization of the cell-based products. A focus will be given to integrative approaches that allow the identification of metabolic hallmarks to support bioprocess development.