Development of method and apparatus for producing lipid particles having desired particle diameter

A system for manufacturing a lipid particle with a desired particle size, the system comprising:

• (A) a first mixing region for preparing a primary diluting solution by mixing a first solution comprising a lipid and alcohol with a second solution comprising water;
• (B) a second mixing region for preparing a secondary diluting solution by mixing the primary diluting solution with a third solution comprising water;
• and
• (C) a liquid supplying tube for supplying the primary diluting solution from the first mixing region to the second mixing region in a predetermined time;
• wherein a particle size of a lipid particle is controlled by adjusting at least one condition selected from the group consisting of a concentration of the alcohol in the primary diluting solution, a concentration of the lipid, the predetermined time, and a temperature upon the mixing.

A system for manufacturing a lipid particle with a desired particle size, the system comprising:

• (1) a lipid particle manufacturing apparatus;
• and
• (2) a dialyzer,
• wherein the particle size manufacturing apparatus comprises:
• (1-A) a first mixing region for preparing a primary diluting solution by mixing a first solution comprising a lipid and alcohol with a second solution comprising water;
• (1-B) a second mixing region for preparing a secondary diluting solution by mixing the primary diluting solution with a third solution comprising water;
• and
• (1-C) a liquid supplying tube for supplying the primary diluting solution from the first mixing region to the second mixing region in a predetermined time;
• wherein a particle size of a lipid particle is controlled by adjusting at least one condition selected from the group consisting of a concentration of the alcohol in the primary diluting solution, a concentration of the lipid, the predetermined time, and a temperature upon the mixing, and the dialyzer comprises:
• (2-A) a hollow fiber dialysis column having a hollow fiber membrane and a first flow channel where a solution subjected to dialysis flows inside the hollow fiber membrane;
• (2-B) a liquid supplying section for supplying the solution subjected to dialysis to an inlet of the first flow channel;
• and
• (2-C) a second flow channel having a portion in contact with the hollow fiber membrane.