Extracellular Microvesicles as New Industrial Therapeutic Frontiers.
Microvesicles (MVs) are subcellular physiological vehicles present in all body fluids that mediate the transfer of intercellular information within biological systems and contribute to healthy conditions. MVs have lipid bilayer membranes decorated with multiple ligands that can interact with receptors on target cells, rendering them as promising candidates for targeted delivery. The biotechnology and cell therapy industries are developing MV-based preparations that use this subcellular therapeutic machinery (in a naïve or modified state) for regenerative medicine, as substitutes for intact cell therapy, and as intelligent targeted drug delivery carriers. However, significant production challenges must be overcome before MVs scale-up development, clinical translation, and routine therapeutic application can be realized. The unique expertise developed in the biotechnology industry should facilitate market access to MV-based therapeutics. In this review, the roles of biotechnology and cell therapy industries to manufacture MVs as inherent therapeutic agents or drug delivery systems are summarized. The manufacturing, development, characterization, and regulatory challenges for successful translation are discussed.
['Agrahari|Vivek|V|', 'Agrahari|Vibhuti|V|', 'Burnouf|Pierre-Alain|PA|', 'Chew|Chee Ho|CH|', 'Burnouf|Thierry|T|']
D001709:Biotechnology D000067128:Extracellular Vesicles D006801:Humans D058990:Molecular Targeted Therapy D044968:Regenerative Medicine D013678:Technology, Pharmaceutical
microvesicles therapies clinical translation delivery systems assessment clinical use extracellular vesicles functions isolation purification tissue regeneration