Considerations for the bioprocessing, manufacture and translation of extracellular vesicles for therapeutic and diagnostic applications

There is growing interest in the potential and use of extracellular vesicles (EVs) for a range of diagnostic and therapeutic applications. EVs have been shown, in some instances, to mediate the regenerative effects elicited by stem cell therapies. As such, they are being studied to identify the extent to which these extracellular bodies can be employed as a therapeutic entity, and significant R&D activity is underway to further understand their clinical and commercial potential. However, successful translation will first require further characterization and standardization of EV production, as well as addressing some of the major challenges associated with their reproducible manufacture. This includes the capacity to produce EVs at a scale that is both clinically and commercially effective. This article will highlight some of the bioprocessing and manufacturing considerations and challenges associated with the standardized production of EVs.