Recent advances in scalable exosome production: Challenges and innovations

Exosomes, nanosized extracellular vesicles (30–150 ​nm), play a crucial role in intercellular communication and are promising biomarkers and therapeutic agents in oncology, neurodegenerative disorders, and immunotherapy. However, their widespread clinical adoption is constrained by challenges in scalable production, efficient purification, and regulatory standardization. This review critically evaluates recent advancements in exosome bioprocessing, including cell source optimization, culture refinement, and next-generation isolation technologies such as microfluidic microarrays and EXODUS systems. Additionally, we address the limitations of current exosome standardization efforts and propose harmonized protocols to enhance reproducibility. Future research should focus on integrating scalable bioreactor-based systems and artificial intelligence-driven quality control frameworks to accelerate exosome applications in precision medicine and regenerative therapy.