TRANSFORM-EV will develop a new, more efficient way to manufacture extracellular vesicles (EVs)—tiny, naturally occurring particles that carry medicines such as nucleic acids, gene editors, and proteins to targeted locations in the body. EVs are promising because they can hold substantial “cargo,” and may cause fewer unwanted immune reactions than some synthetic delivery systems. Currently EVs are expensive and slow to produce, making their production difficult to scale.

The goal of this project is to build innovative continuous manufacturing  capacity specifically designed for EVs, develop improved evaluation and quality-control monitoring EV production and scale the process, setting the stage for future domestic commercial-scale manufacturing. If successful, this effort will potentially benefit related advanced therapies like viral vectors and cell therapies.