Manufactured extracellular vesicles as human therapeutics: challenges, advances, and opportunities

Extracellular vesicles (EVs) have evolved across all phyla as an intercellular communication system. There are intrinsic advantages of leveraging this capability to deliver therapeutic cargo to treat disease, which have been demonstrated in numerous in vivo studies. As with other new modalities, the challenge has now shifted from proof of concept to developing reliable and efficient large-scale infrastructure to manufacture consistently pure and potent drug for broad-based patient access. This review focuses on how this challenge has been met with both existing and emerging technology platforms that are making impressive strides in the industrialization of EV manufacturing. In addition, we also highlight the gaps and opportunities that are beginning to be explored and addressed to hasten ushering in the era of therapeutic EVs.