Scale-up and scale-out of extracellular vesicle production utilizing industrial grade bioreactors

“As research advances and more discoveries emerge, cell-free extracellular vesicle-based therapies are moving steadily closer to clinical reality.”Human stem cell-derived extracellular vesicles (EVs) play critical roles in cell-cell communication and have been shown to have therapeutic effects, ranging from promoting wound healing to reducing inflammation and protecting against neurodegeneration. The major hurdle of EV translation is the development of a process to increase EV production to a scale at which clinical trials are feasible. Industrial scale up utilizing bioreactors are being investigated to increase EV production while maintaining therapeutic efficacy. Bioreactors introduce a dynamic aspect to EV generation that needs to ascertain the effects of shear rate on EV biogenesis and quality. This viewpoint addresses some insights and discoveries on the forefront of EV scaleup.