Method of manufacture of a composition comprising a saponin liposome in a liposomal formulation submicromÉtrica in Liposomes contain a lÍpido and a Sterol

摘要

Claim 1: a procedure for the manufacture of a composition comprising a saponin liposome in a liposomal Formulation in the submicrometric Liposomes contain a Lipid andA Sterol, which comprises the following steps: a) preparation of a first sub Micron liposomal Formulation in which the Liposomes containing Lipid and Sterol,(b) addition of saponin to the first sub Micron liposomal formulation, c) maturation of submicrometric liposomal formulation containing saponin for at least 1, 2, 3, 4, 5, 6, 7.8, 9, 10, 11, 12, 13, 14, 15, 16 hours, and (d) Filtration of the liposomal formulation containing saponin of submicrometric Matured Stage c) through a filter for sterilization.Claim 2: a method according to claim 1, in which the first submicrometric liposomal formulation also contains a tlr-4 agonist.Claim 3: a procedure under any of the preceding Claims, wherein the Lipid is a neutral LIPID.Claim 4: a method according to claim 3 that the neutral is selected between a Lipid phosphatidylcholine phosphatidylcholine from egg yolkDioleoíl phosphatidylcholine (DOPC) or dilauril phosphatidylcholine. Claim 6: a procedure under any of the preceding Claims, wherein the Sterol was cholesterol.Claim 8: a procedure under any of the preceding Claims, in which the saponin QS21 is.9: a claim procedure according to any of the preceding Claims, wherein the tlr-4 agonist is a lipopolysaccharide.Claim 10: a procedure under any of the preceding Claims, wherein the tlr-4 agonist MPL is 3D.Claim 26: a procedure for preparing a vaccine composition which comprises the Proceedings of any of claims 1 to 25 and the combination of the filtered compositionAn Antigen.