Microfluidic Devices for Manufacture of Therapeutic Extracellular Vesicles: Advances and Opportunities

ABSTRACT Extracellular vesicles (EVs) are emerging as promising candidates in therapeutic applications due to their unique ability to mediate intercellular communication and deliver biological cargo. With increasing interest in EV‐based therapies, the development of scalable, cost‐effective and regu...

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Main Authors: Amin Hassanzadeh‐Barforoushi, Xenia Sango, Ella L. Johnston, David Haylock, Yuling Wang
Format: Article
Language:English
Published: Wiley 2025-07-01
Series:Journal of Extracellular Vesicles
Online Access:https://doi.org/10.1002/jev2.70132
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author Amin Hassanzadeh‐Barforoushi
Xenia Sango
Ella L. Johnston
David Haylock
Yuling Wang
author_facet Amin Hassanzadeh‐Barforoushi
Xenia Sango
Ella L. Johnston
David Haylock
Yuling Wang
author_sort Amin Hassanzadeh‐Barforoushi
collection DOAJ
description ABSTRACT Extracellular vesicles (EVs) are emerging as promising candidates in therapeutic applications due to their unique ability to mediate intercellular communication and deliver biological cargo. With increasing interest in EV‐based therapies, the development of scalable, cost‐effective and regulatory‐compliant production methods is critical. Microfluidic platforms offer transformative potential in EV manufacturing, providing precise control over production conditions, enhanced purity and seamless integration with quality control systems. This review highlights the advantages of microfluidic technologies in EV production, including fine‐tuning of shear stress to optimise yield, advanced purification strategies that achieve high recovery and purity, and on‐chip capabilities for EV loading and surface modification. Key challenges such as scaling up production while maintaining sterility, controlling EV release after immunoaffinity capture, and addressing clogging and fouling in microfluidic devices are discussed alongside emerging solutions. Additionally, the integration of AI‐driven automation and real‐time monitoring, as well as personalised EV manufacturing, is explored as pivotal innovations. Future directions emphasise the potential of combining size‐ and affinity‐based methods for EV isolation and aligning microfluidic technologies with regulatory requirements to accelerate clinical translation. Therefore, we believe microfluidics platforms for EV isolation hold immense potential to redefine EV manufacturing by enabling scalable, reproducible and high‐quality production systems essential for therapeutic applications.
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spelling doaj-art-e8e484e6d09d4b6d8b9484dd0bf6ee482025-08-20T03:08:52ZengWileyJournal of Extracellular Vesicles2001-30782025-07-01147n/an/a10.1002/jev2.70132Microfluidic Devices for Manufacture of Therapeutic Extracellular Vesicles: Advances and OpportunitiesAmin Hassanzadeh‐Barforoushi0Xenia Sango1Ella L. Johnston2David Haylock3Yuling Wang4School of Natural Sciences, Faculty of Science and Engineering Macquarie University Sydney NSW AustraliaVivaZome Therapeutics Pty Ltd Melbourne VIC AustraliaVivaZome Therapeutics Pty Ltd Melbourne VIC AustraliaVivaZome Therapeutics Pty Ltd Melbourne VIC AustraliaSchool of Natural Sciences, Faculty of Science and Engineering Macquarie University Sydney NSW AustraliaABSTRACT Extracellular vesicles (EVs) are emerging as promising candidates in therapeutic applications due to their unique ability to mediate intercellular communication and deliver biological cargo. With increasing interest in EV‐based therapies, the development of scalable, cost‐effective and regulatory‐compliant production methods is critical. Microfluidic platforms offer transformative potential in EV manufacturing, providing precise control over production conditions, enhanced purity and seamless integration with quality control systems. This review highlights the advantages of microfluidic technologies in EV production, including fine‐tuning of shear stress to optimise yield, advanced purification strategies that achieve high recovery and purity, and on‐chip capabilities for EV loading and surface modification. Key challenges such as scaling up production while maintaining sterility, controlling EV release after immunoaffinity capture, and addressing clogging and fouling in microfluidic devices are discussed alongside emerging solutions. Additionally, the integration of AI‐driven automation and real‐time monitoring, as well as personalised EV manufacturing, is explored as pivotal innovations. Future directions emphasise the potential of combining size‐ and affinity‐based methods for EV isolation and aligning microfluidic technologies with regulatory requirements to accelerate clinical translation. Therefore, we believe microfluidics platforms for EV isolation hold immense potential to redefine EV manufacturing by enabling scalable, reproducible and high‐quality production systems essential for therapeutic applications.https://doi.org/10.1002/jev2.70132
spellingShingle Amin Hassanzadeh‐Barforoushi
Xenia Sango
Ella L. Johnston
David Haylock
Yuling Wang
Microfluidic Devices for Manufacture of Therapeutic Extracellular Vesicles: Advances and Opportunities
Journal of Extracellular Vesicles
title Microfluidic Devices for Manufacture of Therapeutic Extracellular Vesicles: Advances and Opportunities
title_full Microfluidic Devices for Manufacture of Therapeutic Extracellular Vesicles: Advances and Opportunities
title_fullStr Microfluidic Devices for Manufacture of Therapeutic Extracellular Vesicles: Advances and Opportunities
title_full_unstemmed Microfluidic Devices for Manufacture of Therapeutic Extracellular Vesicles: Advances and Opportunities
title_short Microfluidic Devices for Manufacture of Therapeutic Extracellular Vesicles: Advances and Opportunities
title_sort microfluidic devices for manufacture of therapeutic extracellular vesicles advances and opportunities
url https://doi.org/10.1002/jev2.70132
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