Process and apparatus for producing exosomes

Continuous process for the production of exosomes, comprising:

• a) cell culture with release of exosomes carried out in an incubator obtaining from said incubator a product containing exosomes and an aqueous culture medium;
• b) continuously feeding a first portion of said product to a first side of a concentrator device;
• c) continuously feeding a second portion of said product to a second side of said concentrator device;
• d) wherein said first side and said second side of the concentrator device are in communication with each other via a semi-permeable wall which is permeable to the aqueous culture medium and substantially impermeable to the exosomes;
• e) wherein the transit of a first flow of said product and a second flow of said product respectively through the first side and the second side of the concentrator device causes a passage of the aqueous culture medium from the second side towards the first side, across said wall, and a consequent increase in the concentration of exosomes in the product which transits through the second side;
• f) collecting a product enriched with exosomes from said second side of the concentrator device;
• and
• g) collecting a diluted product from said first side of the concentrator device and recirculating said diluted product to said incubator,
• wherein the aforesaid process steps a)-g) are carried out in a closed loop comprising the cell culture in the incubator and the concentration of the exosomes in the concentrator device.