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STABLE LIQUID ANTIBODY PRODUCT
专利权人:
Пфайзер Инк. (US)
发明人:
БАДКАР Адваит Виджай (US),БОХЭК Лейх Кристен (US),КИНГ Кевин Роджер (US),ЛЭРИ Аланта Лиа (US)
申请号:
RU2011108025/10
公开号:
RU2011108025A
申请日:
2009.09.18
申请国别(地区):
RU
年份:
2012
代理人:
摘要:
1. A liquid composition comprising:! at least one antibody! at least one tonicity agent! at least one buffer,! at least one chelating agent,! at least one surfactant,! where the pH of the composition is from 5.8 to 6.8. ! 2. The liquid composition according to claim 1, consisting essentially of:! at least one antibody! at least one tonicity agent! at least one buffer,! at least one chelating agent,! at least one surfactant,! where the pH of the composition is from 5.8 to 6.8. ! 3. The liquid composition according to claim 1 or 2, wherein the tonicity control agent is a non-reducing sugar, preferably trehalose dihydrate. ! 4. The liquid composition according to claim 3, where the concentration of trehalose dihydrate is from about 1 mg / ml to about 100 mg / ml. ! 5. The liquid composition according to claim 1, where the surfactant is polysorbate, preferably polysorbate 20.! 6. The liquid composition according to claim 5, where the concentration of polysorbate is from about 0.01 to about 0.15 mg / ml ! 7. The liquid composition according to claim 1, where the buffer is a histidine buffer. ! 8. The liquid composition according to claim 7, where the concentration of the histidine buffer is from about 1.0 to about 15 mm. ! 9. The liquid composition according to claim 1, where the chelating agent is a disodium salt of ethylenediaminetetraacetic acid (EDTA), preferably in a concentration of from about 0.01 to about 0.1 mg / ml. ! 10. The liquid composition according to claim 1, where the concentration of the antibody is less than or equal to about 50 mg / ml. ! 11. Liquid to1. Жидкая композиция, содержащая: ! по меньшей мере одно антитело, ! по меньшей мере один агент, регулирующий тоничность, ! по меньшей мере один буфер, ! по меньшей мере один хелатообразующий агент, ! по меньшей мере одно поверхностно-активное вещество, ! где рН указанной композиции составляет от 5,8 до 6,8. ! 2. Жидкая композиция по п.1, состоящая по существу из: ! по меньшей мере одного антите
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