АНДИА Джеймс (US),КЛИЛАНД Джеффри Эл (US),ХСЮ Шанг Си (US),ЛАМ Хантхе Эм (US),ОУВЕКАШИЭ Давид И. (US),ШАЙЕ Стивен Дзей (US),ЯНГ Джанет Ю-Фенг (US),ВУ Сильвия Сау-Ян (US)
申请号：
RU2013141049/15
公开号：
RU2013141049A
申请日:
2013.09.06
申请国别(地区):
RU
年份:
2015
代理人:
摘要：
1. A stable isotonic reconstituted composition containing at least 50 mg / ml protein and a diluent that reconstituted a composition obtained from a lyophilized mixture of protein and lyoprotectant, characterized in that the protein concentration in the reconstituted composition is 2-40 times higher than the concentration of protein in the mixture before lyophilization. 2. The composition according to claim 1, characterized in that the lyoprotector is sucrose and trehalose. The composition according to claim 1, characterized in that it further comprises a buffer solution. The composition according to claim 3, characterized in that the buffer solution is a histidine or succinate buffer. The composition according to claim 1, characterized in that it further comprises a surfactant. A stable reconstituted composition containing an antibody in an amount of at least 50 mg / ml and a diluent that reconstituted a composition obtained from a lyophilized mixture of an antibody and a lyoprotectant, characterized in that the concentration of the antibody in the reconstituted composition is 2-40 times higher than the concentration antibodies in the mixture before lyophilization. 7. The composition according to claim 6, wherein the antibody is an anti-IgE antibody or an anti-HER2 antibody. The composition according to claim 6, characterized in that it is isotonic. A method of obtaining a stable isotonic reconstituted composition, comprising restoring a lyophilized mixture of protein and a lyoprotectant in a diluent, such that the protein concentration in the reconstituted composition is at least 50 mg / ml, characterized in that the protein concentration in the reconstituted composition is about 2-40 times higher than protein concentration in mixture d1. Стабильная изотоническая восстановленная композиция, содержащая белок в количестве, по крайней мере, 50 мг/мл и разбавитель, который восстановил композицию, полученную из лиофилизированной смеси белка и лиопротектора, отличающаяс
