Bioproduction of therapeutic extracellular vesicles from insulin cells – Bioprod-sEVforT1D

Type 1 diabetes (T1D) is a chronic disease caused by the auto-immune destruction of pancreatic beta cells. Small extracellular vesicles (sEV) released by healthy beta cells are promising candidates for T1D therapy thanks to their aptitude to reprogram the autoreactif immune system towards tolerance, to maintain pancreatic function and to prevent pathogenic mechanisms. The aim of the present project is to develop a production flow for sEV from a human beta cell line cultured as 3D-pseudo-islets in a stirred bioreactor and their isolation by tangential filtration and chromatography. To efficiently initialize clinical development of the product, the project addresses outstanding issues related to the commercial manufacturing process.