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REVIEW article

Front. Bioeng. Biotechnol.
Sec. Biofabrication
Volume 13 - 2025 | doi: 10.3389/fbioe.2025.1487627
This article is part of the Research Topic Breakthroughs in Biofabrication View all 7 articles

Advancements in Extracellular Vesicles Biomanufacturing: A Comprehensive Overview of Large-Scale Production and Clinical Research

Provisionally accepted
Ziqian Li Ziqian Li 1Junyu Yan Junyu Yan 1Xiang Li Xiang Li 1Hui Chen Hui Chen 1Chen Lin Chen Lin 1Yuhang Zhang Yuhang Zhang 1Tian Gao Tian Gao 1Yabo Zhang Yabo Zhang 1Yue Shu Yue Shu 1Shuyuan Pan Shuyuan Pan 1Yuntao Zhang Yuntao Zhang 2*
  • 1 Beijing Institute of Biological Products Company Limited, Beijing, China
  • 2 China National Biotec Group Company Limited (CNBG), Beijing, China

The final, formatted version of the article will be published soon.

    Extracellular vesicles (EVs) are nano-sized, membranous structures secreted by cells into the extracellular space, have attracted considerable attention in the field of biosciences for their role in intercellular communication in various physiological and pathological processes. Their ubiquitous presence in bodily fluids and cell-specific characteristics make them promising candidates as biomarkers. Additionally, their ability to transport biological therapeutics across different biological barriers to specific target cells underscores their significant translational potential for diagnostic and therapeutic purposes. Significant progress has been achieved in the translation of EVs research to clinical applications, however, challenges persist in the large-scale production of EVs, particularly in the areas of scalable manufacturing, efficient isolation methods, drug loading techniques, and advanced characterization technology. This review critically examines the complex processes involved in EVs biogenesis and explores recent developments in large-scale EVs production. By synthesizing knowledge from these fields, this review aims to provide a holistic perspective on the evolving landscape of EVs research and its applications, underscoring both the accomplishments and the obstacles that lie ahead in fully realizing the potential of EVs in biomedicine.

    Keywords: extracellular vesicles, biomarkers, Drug delivery, Large-scale production, characterization

    Received: 28 Aug 2024; Accepted: 28 Jan 2025.

    Copyright: © 2025 Li, Yan, Li, Chen, Lin, Zhang, Gao, Zhang, Shu, Pan and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Yuntao Zhang, China National Biotec Group Company Limited (CNBG), Beijing, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.