Cell and gene therapies have been called the emerging fourth pillar of healthcare systems. However, recent research suggests that the cell therapy pillar may, in fact, be underpinned by exosomes (also referred to as small extracellular vesicles; sEVs). David Haylock at VivaZome Therapeutics and Andrew Hill at La Trobe University describe the key aspects of extracellular vesicle biology, opportunities for exploiting this biology, manufacturing challenges in the production of safe and effective exosome therapies, and regulatory considerations for this new class of biological medicines.

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