A paper entitled “Development of an optimized and scalable method for isolation of umbilical cord blood‐derived small extracellular vesicles for future clinical use” was just published in STEM CELLS Translational Medicine. The publication details the protocol developed and optimized by Exogenus Therapeutics for the productionof Exo–101.
Our team isolates small extracellular vesicles (EV) from ischemia pre–conditioned umbilical cord blood mononuclear cells,using a combination of ultra–filtration (UF) and size–exclusion chromatography (SEC). This methodology yields more vesicles than the ultracentrifugation gold standard, and has the added benefit of being easy to standardize and scale–up. Theresulting product is enriched in vesicles smaller than 200nm, which our team characterized in depthin order to propose a set of measures for quality control.The paper furthermore demonstrates Exo–101’s therapeutic benefit in vitro and in an animalmodel of delayed wound healing. By using UF/SEC, we show that it is possible to achieve a high–quality, standardized product, using methods ofmass production that can be applied to a GMO settingfor clinical applications.