Overcoming Manufacturing And Delivery Barriers To Unlock The Potential Of EV-Based Therapies

In this segment of Cell & Gene Live, Redefining CGTs with Exosomes and EVs, Aegle Therapeutics’ Dr. Gloria Matthews identifies manufacturing scale-up as both the key progress point and the biggest challenge in translating extracellular vesicle (EV) therapies from lab to clinic. While regulatory comfort with cell therapies has helped pave the way, defining release assays and potency for EVs remains complex. Near-term success is expected in locally delivered applications, such as dermatologic, ocular, and CNS conditions, due to easier logistics and regulatory pathways, while systemic diseases like autoimmune disorders may take longer to reach clinical viability due to dosing and targeting challenges.