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New manufacturing platform facilitates the development of extracellular vesicle-based therapies

- Research

Photo source: BST

A study led by researchers from the Germans Trias i Pujol Research Institute (IGTP) and the Blood and Tissue Bank (BST) has developed and validated a manufacturing platform for extracellular vesicles that meets pharmaceutical quality requirements, marking a key step towards their clinical application.

Extracellular vesicles are small particles released by cells that carry molecules capable of transmitting biological information and modulating cellular responses, such as inflammation. Vesicles derived from mesenchymal stromal cells are attracting growing interest in regenerative medicine due to their therapeutic potential. However, translating these approaches from the laboratory into clinical practice requires standardised, reproducible manufacturing processes that meet pharmaceutical quality requirements.

In this context, a study led by researchers from IGTP's Heart Failure and Cardiac Regeneration Research Group (ICREC) and BST, published in the journal iScience, presents a platform for manufacturing extracellular vesicles derived from umbilical cord mesenchymal stromal cells. The platform combines a bioreactor-based culture system with two consecutive concentration and purification techniques, under chemically defined culture conditions free from animal-derived components.

The process, semi-automated and developed at an intermediate scale, enabled the production of preparations with consistent quality and stability characteristics across batches.

Manufacturing environment and systems compliant with Good Manufacturing Practice (GMP). Top left: operators equipped for aseptic interventions in a cleanroom; top right: Grade C cleanroom for bioreactor culture operations. Bottom left: adapted ÄKTA Flux S system for tangential flow filtration (TFF); bottom right: adapted and automated ÄKTA go system for size-exclusion chromatography (SEC)

The platform complies with good manufacturing practice (GMP) requirements and addresses one of the main challenges in developing extracellular vesicle-based therapies: establishing robust and reproducible manufacturing processes.

"To enable extracellular vesicles to be used in future therapies, we need manufacturing processes that can deliver safe products of consistent quality. This platform helps us move in that direction", explains Santiago Roura, researcher in the ICREC Group at IGTP and corresponding author of the study.

"This collaborative project reflects the strong commitment of the Blood and Tissue Bank to the clinical translation of new developments with therapeutic potential. Integrating robust, reproducible and scalable processes is essential to transforming innovative research into safe, tangible and accessible therapies for patients", adds Joaquim Vives, senior researcher and group leader at BST.

The findings provide a foundation for further progress towards the potential clinical application of these products. Potential applications include regenerative medicine and, in particular, the development of new therapeutic strategies for cardiovascular diseases.


Reference

Courageux Y, Monguió-Tortajada M, López-Fernández A, Schoch L, Poblador F, Morini S, Prat-Vidal C, Rodriguez L, Torrents S, Aran G, Codinach M, Gálvez-Montón C, Bayes-Genis A, Vives J, Querol S, Roura S. Design and validation of a GMP-compliant manufacturing platform of extracellular vesicles from mesenchymal stromal cells. iScience. 2026;29(11):117881. DOI: 10.1016/j.isci.2026.117881.