Extracellular Vesicle-Based Drug Overview: Research Landscape, Quality Control, and Nonclinical Evaluation Strategies

Extracellular vesicles (EVs) have emerged as promising therapeutic agents due to their ability to transfer bioactive cargo to target cells, offering potential treatments for various diseases. Despite their promise, challenges such as understanding mechanisms, engineering modifications, and establishing quality control hinder their clinical translation. Currently, no specific regulatory guidelines exist for EV-based drugs, complicating their development. This review highlights the current research landscape, quality control strategies, and nonclinical evaluation of EV-based drugs, aiming to expedite their clinical application and benefit patients.