IGTP and BST validate GMP-compliant platform for extracellular vesicle manufacturing

Researchers at the Germans Trias i Pujol Research Institute (IGTP) and the Blood and Tissue Bank (BST) have developed and validated a manufacturing platform for extracellular vesicles that meets pharmaceutical quality requirements, which the two institutions call a key step toward using the particles in the clinic, according to a report carried by Phys.org.

Extracellular vesicles are small particles released by cells, carrying molecules that can transmit biological information and modulate cellular responses such as inflammation. Vesicles derived from mesenchymal stromal cells have drawn growing interest in regenerative medicine for their therapeutic potential, but moving that work from the laboratory into clinical practice requires manufacturing processes that are standardized, reproducible, and built to pharmaceutical quality requirements. The platform described here, built by IGTP's Heart Failure and Cardiac Regeneration Research Group (ICREC) with BST and published in the journal iScience, targets vesicles derived from umbilical cord mesenchymal stromal cells.

The design pairs a bioreactor-based culture system with two consecutive concentration and purification steps, run under chemically defined culture conditions that contain no animal-derived components. Concentration uses tangential-flow filtration on an adapted AKTA Flux S system; purification follows by size-exclusion chromatography on an adapted and automated AKTA go system. Culture and aseptic handling take place in a manufacturing environment and with systems compliant with good manufacturing practice, or GMP, the standard regulators require before a biological product can reach patients; bioreactor operations run in a Grade C cleanroom, with operators equipped for aseptic work.

IGTP and BST report, in the iScience study, that the process, semiautomated and developed at an intermediate scale, produced preparations with consistent quality and stability characteristics across batches. That consistency is the specific problem the platform was built to address: establishing a manufacturing process for extracellular vesicles that is robust and reproducible.

Santiago Roura, a researcher in the ICREC group at IGTP and the study's corresponding author, said, in comments carried by Phys.org, that enabling extracellular vesicles for future therapies requires manufacturing processes able to deliver products that are safe and consistent in quality, and that this platform moves that effort forward. Joaquim Vives, a senior researcher and group leader at BST, said the project reflects the blood bank's commitment to carrying research with therapeutic potential toward clinical use, and that building processes that are robust, reproducible, and scalable is what allows laboratory findings to become therapies patients can receive.

The institutions frame the result as a foundation for further work toward potential clinical use, including regenerative medicine and, in particular, new therapeutic strategies for cardiovascular disease. The platform has validated a manufacturing process, not a therapy; neither institution has reported testing these vesicles in patients.