Scale-Up Production, Standardization and Biomaterialomics of Extracellular Vesicles

Dear Colleagues,

This Special Issue will focus on the critical challenges and opportunities in extracellular vesicle (EV) research that enable their translation from the laboratory to clinical and industrial applications. We particularly welcome studies that go beyond molecular characterization to address scalable production strategies, the harmonization of isolation and analysis methods, and integrative multi-omics approaches to EV composition and functionality. By advancing these areas, we aim to accelerate the development of EV-based diagnostics, therapeutics, and their integration with biomaterial science.

Extracellular vesicles are emerging as powerful mediators of intercellular communication, with wide-ranging applications from regenerative medicine to advanced biointerfaces. Realizing this potential requires progress on several fronts: robust bioprocessing systems (e.g., stirred-tank and hollow-fiber bioreactors) for large-scale production; standardized isolation, purification, and characterization pipelines that meet regulatory and clinical requirements; and reliable markers of EV quality to ensure reproducibility, safety, and therapeutic efficacy. 

For this Special Issue, we invite original research articles, reviews, and perspectives that explore these frontiers and propose innovative solutions. 

Topics of interest include, but are not limited to, the following: 

Innovative EV production (e.g., scalable culture systems, stirred-tank, and hollow-fiber bioreactors);

Downstream processing and purification (tangential flow filtration, chromatography, and advanced separation technologies);

Characterization methods;

Nanoscale flow cytometry and high-resolution single-particle analysis;

Spectroscopic and imaging approaches (Raman, FTIR, and super-resolution microscopy);

Light scattering and particle analysis (static and dynamic light scattering, and nanoparticle tracking analysis);

Mass spectrometry-based profiling (MALDI-TOF and LC–MS/MS);

Advanced electron microscopy (cryo-TEM, tomography, and functional imaging biomarkers);

Analytical and omics approaches (proteomics, transcriptomics, lipidomics, metabolomics, and integrative multi-omics);

Novel insights into EV subtypes (mitovesicles, cytoskeletal components, and mtDNA cargo);

Artificial intelligence and machine learning in EV research (pattern recognition, predictive biomarkers, and quality control);

Alternative sources of EVs (algal, fungal, microbial, and plant-derived vesicles);

Clinical and translational applications (tear and saliva EVs, regenerative medicine, immunomodulation, and drug delivery);

Regulatory and GMP-compliant production (standardization, QA/QC frameworks, reproducibility, and safety testing);

Data Management and FAIR Principles (big data handling, repositories, and metadata standards). 

Through this Special Issue, we aim to provide a platform for innovative studies and perspectives that will strengthen the foundations of EV science and accelerate translation into real-world clinical and industrial impact.

Dr. Esra Cansever Mutlu
Prof. Dr. Artemis Stamboulis
Dr. Joshua Price
Guest Editors

Manuscript Submission Information

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Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Bioengineering is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

• extracellular vesicles
• exosomes
• regenerative medicine
• drug delivery
• nanoscale flow cytometry
• cryo-electron microscopy
• mass spectrometry
• multi-omics integration
• AI and machine learning
• FAIR data principles