ЧЕССАЛОВ Сергей (MA),КАНТОР Анджела (MA),ЛИ Ли (MA),ЛУКША Николас (US),УОРН Николас (US)
申请号：
RU2011151286/15
公开号：
RU2011151286A
申请日:
2010.06.18
申请国别(地区):
RU
年份:
2013
代理人:
摘要：
1. A formulation containing a lyophilized mixture of a small modular immunopharmaceutical protein, where less than 7% of the lyophilized small modular immunopharmaceutical protein exists in aggregated form. The formulation of claim 1, further comprising an excipient selected from the group consisting of sucrose, mannitol, glycine, sodium chloride, dextran, trialose and combinations thereof and / or a buffer selected from the group consisting of histidine, sodium acetate, citrate, phosphate, succinate , Tris and combinations thereof. 3. The formulation according to claim 2, where the mass ratio of non-reducing sugar to a small modular immunopharmaceutical protein is approximately 0.1: 1, 0.2: 1, 0.25: 1, 0.4: 1, 0.5: 1, 1: 1, 2: 1, 2.6: 1, 3: 1, 4: 1 or 5: 1.4. The formulation of claim 2, wherein the formulation further comprises a stabilizer selected from the group consisting of sucrose, sorbitol, mannitol, glycine, trialose, and combinations thereof. The formulation of claim 4, wherein the formulation further comprises an isotonic agent selected from the group consisting of glycine, sorbitol, sucrose, mannitol, sodium chloride, dextrose, arginine, and combinations thereof. The formulation of claim 5, wherein the formulation further comprises a surfactant selected from the group consisting of Polysorbate 20, Polysorbate 80, poloxamers, Triton, and combinations thereof. A formulation containing a lyophilized mixture of a small modular immunopharmaceutical protein, sucrose, histidine, methionine and Polysorbate 80.8. The formulation of claim 7, comprising approximately 50 mg / ml small modular immunopharmaceutical protein, approximately 10 mM histidine, approximately 10 mM methionine, approximately 5% sucrose, and approximately 0.01% Polysorbate 80.9. The formulation of claim 7, comprising1. Рецептура, содержащая лиофилизированную смесь малого модульного иммунофармацевтического белка, где меньше чем 7% лиофилизированного малого модульного иммунофармацевтического белка
