Guidelines for clinical translation and commercialization of extracellular vesicles and exosomes based therapeutics

Extracellular vesicles (EVs) are lipid-bilayer delimited membrane structures released by cells, and play a role in intercell communication and disease development. The Global market for EVs in diagnostic and therapeutic applications is expanding. This review maps the current status of EV industry, summarizes the recent advances in EV manufacturing, and focuses on preclinical research involving EVs. The complexity and heterogeneity of EVs provide new opportunities for the development of clinical-grade EV products. The standardization of manufacturing and robust quality control must meet all the Food and Drug Administration requirements and expectations. We believe the evolution of EV research and their mass production with stringency will open a new era of EV-based products in the near future.