Extracellular vesicle manufacture via FACTORY: fully automated collection technology and optimum machinery for clinical translational applications

Extracellular vesicles (EVs) hold significant potential as therapeutic agents and drug carriers. However, current isolation techniques severely limit their clinical application, due to heavy reliance on manual operation, making large-scale isolation of EVs impractical and failing to meet the requirements for clinical translation. Here, we set up the fully automated collection technology and optimum machinery (FACTORY) platform, allowing the efficient collection of high-quality EVs. The platform integrates continuous flow centrifugation and tangential flow filtration (TFF) technologies, achieving a seamless process for the removal of impurities and collection of EVs, thereby ensuring that large scale-manufactured EVs are sterile, mycoplasma free, and low in endotoxins, and exhibit good consistency. We successfully obtained a substantial quantity of EVs utilizing FACTORY, and systematically characterized their EV-specific markers, biological functions, and therapeutic effects. Results indicated that FACTORY significantly promotes the clinical translation of EVs, thereby laying a solid foundation for their application in drug delivery and beyond.