Bacterial Extracellular Vesicles in Biomedical Research and Clinical Translation

Bacterial Extracellular Vesicles (bEVs) are lipid (single- or double-bilayer) nanostructures secreted by virtually all bacteria that play fundamental roles in intercellular communication and have emerged as powerful, multifunctional tools in biomedicine. Their intrinsic ability to encapsulate and protect diverse biomolecules (including proteins, nucleic acids, lipids, metabolites and immunomodulatory factors) makes them highly attractive for therapeutic and diagnostic applications. Recent advances in molecular and synthetic biology have further expanded the biomedical potential of bEVs through targeted bioengineering strategies such as genetic manipulation, surface functionalisation, glycoengineering and modular display technologies, enabling the scalable production of customised bEVs with enhanced safety, stability, targeting precision and functional versatility. These innovations have unlocked a broad range of applications, including licenced and experimental vaccines, immune modulation strategies, drug delivery systems, diagnostic tools and regenerative medicine approaches. Despite this progress, key translational challenges remain, particularly regarding scalability, safety, standardisation and regulatory frameworks and addressing these issues will be critical for the successful integration of bEV-based technologies into novel therapeutic and diagnostic platforms.