@article{4b2c188b830b49a7bbb24291795803c0,
title = "Extracellular Microvesicles as New Industrial Therapeutic Frontiers",
abstract = "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 na{\"i}ve 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.",
keywords = "assessment, clinical translation, clinical use, delivery systems, extracellular vesicles, functions, isolation, microvesicles, purification, therapies, tissue regeneration",
author = "Vivek Agrahari and Vibhuti Agrahari and Burnouf, \{Pierre Alain\} and Chew, \{Chee Ho\} and Thierry Burnouf",
note = "Funding Information: This study was supported by a grant 107-2314-B-038-084 from the Ministry of Science and Technology (MOST) of Taiwan to Thierry Burnouf, Taipei Medical University, Taiwan, and Single Discipline Faculty Development Grant from Shenandoah University , Winchester, VA, USA to Vibhuti Agrahari. Apoptotic body a vesicle containing parts of a dying cell. Conditioned medium culture medium used to grow cells and which contains various substances, including MVs, released by cells. Contract manufacturing organization company that provides pilot-scale manufacturing services of new therapeutic drug candidate batches for preclinical studies and clinical trials. Downstream processing all the production steps implemented to purify and formulate a source material into a product, meeting intended quality specifications for a particular clinical application. Enhanced permeability and retention a concept by which molecules of certain sizes tend to passively accumulate more in tumor tissues than in normal tissues. Exosomes extracellular vesicles released from cells upon fusion of an endocytic compartment multivesicular body with the plasma membrane. Extracellular vesicles (EVs) subcellular phospholipid bilayer nano-/microstructures released by cells in their fluidic microenvironment, and instrumental in cell–cell communications. Good manufacturing practice (GMP) a legally binding system, part of quality assurance, to ensure that products are consistently produced and controlled according to quality standards approved by regulatory authorities. Mesenchymal stromal cells (MSCs) multipotent stromal cells that can differentiate into a variety of cell types. Microvesicles (MVs) generated by the outward budding and fission of membrane vesicles from the cell surface. Regenerative medicine branch of medicine that aims to promote tissue repair and regeneration through use of a range of therapies and clinical procedures. Targeted Drug delivery systems (DDSs) technology that actively delivers a drug in an appropriate manner to the desired site under conditions intended to limit systemic toxicity. Tissue regeneration regrowth of damaged or missing tissue from the remaining tissue. Publisher Copyright: {\textcopyright} 2018 Elsevier Ltd",
year = "2019",
month = jul,
day = "1",
doi = "10.1016/j.tibtech.2018.11.012",
language = "English",
volume = "37",
pages = "707--729",
journal = "Trends in Biotechnology",
issn = "0167-7799",
publisher = "Elsevier Ltd",
number = "7",
}