| 主权项 |
1. A system for sterilely preparing a lipid-nucleic acid nanoparticle, comprising:
a 1st holding unit for holding an organic lipid solution comprising lipids in a water-miscible organic solvent, wherein the 1st holding unit comprises an inlet opening for receiving the organic lipid solution and an exit port for delivering the organic lipid solution; a 2nd holding unit for holding an aqueous solution comprising an RNA molecule, wherein the 2nd holding unit comprises an inlet opening for receiving the aqueous solution and an exit port for delivering the aqueous solution; a mixing unit for mixing the organic lipid solution and the aqueous solution to produce a fluid mixture, wherein the mixing unit comprises a first inlet opening for receiving the organic lipid solution by a 1st connection from the 1st holding unit to the mixing unit, a second inlet opening for receiving the aqueous solution by a 2nd connection from the 2nd holding unit to the mixing unit, and an exit port for delivering the fluid mixture; a 3rd holding unit for holding an aqueous buffer, wherein the 3rd holding unit comprises an inlet opening for receiving the aqueous buffer and an exit port for delivering the aqueous buffer; a dilution unit for diluting the fluid mixture with the aqueous buffer to produce a diluted fluid mixture, wherein the dilution unit comprises a 1st inlet opening for receiving the aqueous buffer by a 3rd connection from the 3rd holding unit to the dilution unit, a 2nd inlet opening for receiving the fluid mixture by a 4th connection from the mixing unit to the dilution unit, and an exit port for delivering the diluted fluid mixture; a concentrating unit comprising a transflow filter for concentrating and removing the organic solvent from the diluted fluid mixture to produce a filter retentate, wherein the concentrating unit comprises an inlet opening for receiving the diluted fluid mixture by a 5th connection from the dilution unit to the concentrating unit, and an exit port for delivering the filter retentate; and a vessel for collecting the filter retentate, wherein the vessel comprises an inlet opening for receiving the filter retentate by a 6th connection from the concentration unit to the vessel and an exit port for delivery of the filter retentate; wherein the system consists of components that are sterilized and disposable so as to be adapted for single batch usage. |
