Tackling EV Manufacturing Challenges

In this segment of Cell & Gene Live, Redefining CGTs with Exosomes and EVs, Aegle Therapeutics’ Dr. Gloria Matthews addresses batch-to-batch variability in EV production by tightly controlling donor selection and standardizing manufacturing processes, though inherent biological differences still present challenges. Her team emphasizes setting practical release criteria and continuously evaluating which product attributes truly impact therapeutic performance, acknowledging that full clarity is still evolving. While automation may help improve consistency, Aegle sees closed-system manufacturing as more critical due to the need for sterility without damaging fragile EVs and believes some degree of human oversight will remain essential given the nuanced nature of cell-based products.