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POWDER PROTEIN COMPOSITIONS AND METHODS FOR PRODUCING THEM
专利权人:
ЭББОТТ ГМБХ УНД КО. КГ (DE)
发明人:
АДЛЕР Михель (DE),КРАУЗЕ Ханс-Юрген (DE),ЗИДЛЕР Михель (DE),ЛАССНЕР Петер (DE),ЛИ Джеффри (DE)
申请号:
RU2014138803
公开号:
RU2014138803A
申请日:
2014.09.25
申请国别(地区):
RU
年份:
2016
代理人:
摘要:
1. A method for producing a powder protein or peptide, comprising the steps of: spray-drying a solution containing more than about 50 mg / ml protein or peptide and at least one excipient, so that a powder protein or peptide is obtained. The method of claim 1, wherein the solution contains more than about 100 mg / ml protein or peptide. A method according to any one of the preceding claims, comprising producing a powder antibody, comprising: spray drying a solution containing more than about 50 mg / ml of an antibody or antigen binding fragment thereof and at least one excipient, so that a powder antibody is obtained. The method of claim 3, wherein the solution contains more than about 100 mg / ml of the antibody or antigen binding fragment thereof. The method of claim 4, wherein the antibody or antigen binding fragment thereof is immunoglobulin G (IgG). The method of claim 4 or 5, wherein the antibody or antigen binding fragment thereof is MAK 195F, adalimumab, ABT-325, ABT-308, or ABT-147.7. The method according to any one of paragraphs. 1, 2, 4, 5, where the powder is stable at ambient temperature and humidity for at least three months. The method according to any one of paragraphs. 1, 2, 4, 5, where the powder is stable at 40 ° C for at least three months. The method according to any one of paragraphs. 1, 2, 4, 5, where the excipient is trehalose, sucrose, sorbitol, polyethylene glycol, at least one amino acid, histidine, alanine, arginine, glycine, or a mixture thereof. 10. The method according to any one of paragraphs. 1, 2, 4, 5, where the solution has an excipient: protein ratio of from about 0.27: 1.0 to about 2.8: 1.0.11. The method according to any one of paragraphs. 1, 2, 4, 5, where the solution has a mass ratio of excipient: protein from about 0.27: 1.0 to about 1.4: 1.0.12. The method according to any one of paragraphs. 1, 2, 4, 5, where the solution has a mass ratio of excipient: protein from about 0.27: 1.0 to about1. Способ получения порошкового бе
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