CHAPTER 12: Standardization and Commercialization of Extracellular Vesicles

Tiny vesicles have made a big impact in both research and business spotlights. With >20 000 related publications listed on PubMed, >2000 filed patents, >250 registered clinical trials, and diagnostic tests being one step from U.S. Food and Drug Administration (FDA) clearance, extracellular vesicles (EVs) are boldly heading towards commercialization. However, they are not there yet. Huge expectations – fuelled by the prolific portfolio of the appealing EV traits, which include clinical translation as multiplexed biomarkers, precision vectors for drugs and biologicals, effectors in regenerative medicine and vaccines – are starting to deliver dizzying deals worth billions of dollars so that super-funded start-ups as well as big pharma companies are now buying into EVs. In addition, the market waiting room is getting, day by day, more and more crowded with analogous/new applications in consumer care and veterinary medicine. However, technology and regulatory hurdles still firmly hold back EVs' true market potential. This chapter will attempt to provide a first guide through the burgeoning jungle of premises, drivers and barriers to EV standardization and commercial exploitation.