Measurement and Standardization Challenges for Exosome-Based Delivery Vectors
Bryant C. Nelson, Lili Wang, Samantha D. Maragh, Paul C. DeRose, Elzafir B. Elsheikh, Wyatt N. Vreeland, Ionita Ghiran, Jennifer Jones
Extracellular vesicles (EVs), and in particular exosomes, have the potential to revolutionize the development and efficient delivery of clinical therapeutics. In this Perspective, we focus on providing a brief introduction to the landscape of exosome-based vectors that are being developed for the delivery of protein- and nucleic acid-based therapeutics. The Perspective represents our opinion on the most pressing measurement and standardization challenges that are limiting the translation of EVs from the bench to the clinic. Current challenges limiting the development of EVs for drug delivery are the lack of (1) standardized cell-based platforms for the production of EV-based therapeutics, (2) reference material EV preparations for establishing measurement assurance and (3) standardized measurement systems for determining the molecular composition of EVs.