Extracellular vesicles (EVs) derived from mesenchymal stromal cells and method for obtaining said EVs

A process for the manufacturing of a pharmaceutical composition of Extracellular Vesicles (EVs) derived from mesenchymal stromal cells (MSCs), said method comprising:

• culturing and expanding MSCs in a serum-free and xeno-free medium comprising human albumin at a concentration between 1 g/l and 5 g/l and human transferrin at a concentration between 55 mg/l and 100 mg/l;
• collecting a cell supernatant from said MSCs, wherein said cell supernatant comprises EVs;
• filtering said cell supernatant to obtain EVs, wherein said filtering is a two-step filtration process comprising filtering said cell supernatant with a filter having a mesh size of between 1 and 5 μm and bringing a filtrate of the first filtration step over a second filter having a mesh size of below 1 μm;
• and
• concentrating a filtrate of the filtering using a tangential flow filtration (TFF) step with a cut-off of 100 kDa.