Article
Enabling Mesenchymal Stromal Cells and Their Extracellular Vesicles Clinical Availability—A Technological and Economical Evaluation
Journal of Extracellular Vesicles
— 2025 — Wiley
Key information
Authors:
Published in
03/17/2025
Abstract
Mesenchymal stromal cell-derived extracellular vesicles (MSC-EVs) have shown significant therapeutic potential across a wide range of clinical conditions, complementing the progress of MSC-based therapies, some of which have already received regulatory approval. However, the high cost of these therapies has limited their accessibility, creating an urgent need to explore manufacturing strategies that reduce the cost of goods and selling prices. This study presents the design and simulation of a scalable manufacturing platform for the co-production of clinical-grade MSC and MSC-EVs using SuperPro Designer. Various production scenarios were evaluated to maximise manufacturing capacity while analysing their impact on economic performance. Our findings demonstrate that for MSC-EVs doses containing 1010 and 1011 particles, selling prices range from 166 to 309€ and from 1659 to 3082€, respectively. For clinical doses of MSC, selling prices vary between 965 and 42,673€ depending on dose size and production scale. Importantly, the co-production approach enables cost-sharing between products, contributing to significantly lower prices compared to individual production. Overall, the proposed platform achieved an attractive payback time of 3 years and a return on investment of 36%. By increasing the number of staggered production units, further price reductions and improved economic metrics could be attained. In conclusion, this study highlights the potential of the proposed manufacturing platform to deliver cost-effective, clinical-grade MSC and MSC-EVs products, advancing the field of regenerative medicine and enhancing the accessibility of these innovative treatments.
Publication details
Authors in the community:
Ricardo Miguel Medalha da Silva
ist193806
Sara Alexandra Peça de Sousa Rosa
ist176831
José António Leonardo dos Santos
ist12311
Publication version
AM - Accepted manuscript
Publisher
Wiley
Link to the publisher's version
https://isevjournals.onlinelibrary.wiley.com/doi/10.1002/jex2.70037
Title of the publication container
Journal of Extracellular Vesicles
First page or article number
e70037
Volume
4
Issue
3
Fields of Science and Technology (FOS)
industrial-biotechnology - Industrial Biotechnology
Keywords
- Extracellular vesicles
- mesenchymal stromal cells
- SuperPro Designer
- manufacturing platform
Publication language (ISO code)
eng - English
Rights type:
Only metadata available
Creative Commons license
CC-BY - CC-BY
Financing entity
HORIZON EUROPE Framework Programme
Title of the project, award or grant: Digitalisation of Biomanufacturing of Plasmids for the Development of Advanced Therapy Modalities
Funding Stream: Twinning (HORIZON-WIDERA-2023-ACCESS-02)
Identifier for the funding entity: https://doi.org/10.13039/100018693
Type of identifier of the funding entity: Crossref Funder
Number for the project, award or grant: 101159993
Financing entity
Fundação para a Ciência e a Tecnologia
Title of the project, award or grant: Institute for Bioengineering and Biosciences
Identifier for the funding entity: https://doi.org/10.13039/501100001871
Type of identifier of the funding entity: Crossref Funder
Number for the project, award or grant: UIDB/04565/2020, UIDP/04565/2020
Financing entity
Fundação para a Ciência e a Tecnologia
Title of the project, award or grant: Associate Laboratory Institute for Health and Bioeconomy-i4HB
Identifier for the funding entity: https://doi.org/10.13039/501100001871
Type of identifier of the funding entity: Crossref Funder
Number for the project, award or grant: LA/P/0140/2020
Financing entity
Fundação para a Ciência e a Tecnologia
Title of the project, award or grant: PhD fellowships
Identifier for the funding entity: https://doi.org/10.13039/501100001871
Type of identifier of the funding entity: Crossref Funder
Number for the project, award or grant: UI/BD/151062/2021; SFRH/BD/148437/2019
Financing entity
Fundação para a Ciência e a Tecnologia
Title of the project, award or grant: EXPRO
Identifier for the funding entity: https://doi.org/10.13039/501100001871
Type of identifier of the funding entity: Crossref Funder
Number for the project, award or grant: PTDC/EQU-EQU/31651/2017