Enabling Mesenchymal Stromal Cells and Their Extracellular Vesicles Clinical Availability—A Technological and Economical Evaluation

Ricardo M. Silva; Sara S. Rosa; José A. L. Santos; Ana M. Azevedo; Ana Fernandes-Platzgummer

Informações chave

Autores:

Ricardo M. Silva (Ricardo Miguel Medalha da Silva); Sara S. Rosa (Sara Alexandra Peça de Sousa Rosa); José A. L. Santos (José António Leonardo dos Santos); Ana M. Azevedo (Ana Margarida Nunes da Mata Pires de Azevedo); Ana Fernandes-Platzgummer (Ana Margarida Pires Fernandes Platzgummer)

Publicado em

17/03/2025

Resumo

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.

Detalhes da publicação

Autores da comunidade :

Ricardo Miguel Medalha da Silva
ist193806
Sara Alexandra Peça de Sousa Rosa
ist176831
José António Leonardo dos Santos
ist12311
IST > iBB
Instituto de Bioengenharia e Biociências
IST > CEBQ
Centro de Engenharia Biológica e Química
IST > DBE
Departamento de Bioengenharia
Ana Margarida Nunes da Mata Pires de Azevedo
ist30470
IST > iBB
Instituto de Bioengenharia e Biociências
IST > DBE
Departamento de Bioengenharia
IST
Instituto Superior Técnico
Ana Margarida Pires Fernandes Platzgummer
ist46782

Versão da publicação

AM - Versão aceite após revisão

Editora

Wiley

Ligação para a versão da editora

https://isevjournals.onlinelibrary.wiley.com/doi/10.1002/jex2.70037

Título do contentor da publicação

Journal of Extracellular Vesicles

Primeira página ou número de artigo

e70037

Volume

4

Fascículo

3

DOI

10.1002/jex2.70037

Domínio Científico (FOS)

industrial-biotechnology - Biotecnologia Industrial

Palavras-chave

Extracellular vesicles
mesenchymal stromal cells
SuperPro Designer
manufacturing platform

Idioma da publicação (código ISO)

eng - Inglês

Acesso à publicação:

Acesso apenas a metadados

Licença Creative Commons

CC-BY - CC-BY

HORIZON EUROPE Framework Programme

Nome da bolsa/projeto: Digitalisation of Biomanufacturing of Plasmids for the Development of Advanced Therapy Modalities

Visitar projeto

Fonte de financiamento: Twinning (HORIZON-WIDERA-2023-ACCESS-02)

Identificador da Entidade Financiadora: https://doi.org/10.13039/100018693