Scalable expansion of human pluripotent stem cells for biomanufacturing cellular therapeutics

Human pluripotent stem cells (hPSCs) hold great promise as cellular therapeutics and in vitro models of disease. These applications require advances in hPSC biomanufacturing in scalable cultivation systems. Stirred suspension bioreactors (SSBs), which are commonly utilized for the production of biologics, afford real-time monitoring and tight control of the culture environment. Stem cell expansion has been demonstrated in this modality but knowledge is currently limited of how the bioreactor milieu influences hPSC physiology. Here, relevant findings are discussed on the effects of adjustable factors such as dissolved oxygen, hydrodynamic cues, and composition of media on the expansion of hPSCs. Greater understanding of the links between cultivation conditions and hPSC self-renewal and propensity for differentiation will be essential for the rational design of processes to robustly biomanufacture hPSC products for clinical use.