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LIQUID COMPOSITION CONTAINING HIGH CONCENTRATION ANTIBODY
专利权人:
ЧУГАИ СЕЙЯКУ КАБУСИКИ КАЙСЯ (JP);Ф.ХОФФМАНН-ЛЯ РОШ АГ (CH)
发明人:
МОРИТИКА Тосиюки (JP),КАМЕОКА Дайсуке (JP),ИМАЕДА Йосими (JP),МАЕДА Терутоси (JP),ШТАУХ Оливер Борис (DE)
申请号:
RU2010131179/15
公开号:
RU2010131179A
申请日:
2008.12.26
申请国别(地区):
RU
年份:
2012
代理人:
摘要:
1. A stable antibody-containing liquid composition, characterized in that it contains arginine and methionine. ! 2. The composition of claim 1, further comprising a histidine buffering agent. ! 3. The composition of claim 2, further comprising a surfactant. ! 4. The composition according to any one of claims 1 to 3, containing the antibody in an amount of at least 50 mg / ml. ! 5. The composition according to any one of claims 1 to 3, containing the antibody in an amount of at least 100 mg / ml. ! 6. The composition according to any one of claims 1 to 3, containing the antibody in an amount of at least 120 mg / ml. ! 7. The composition according to any one of claims 1 to 3, where the antibody is an antibody to an IL-6 receptor. ! 8. The composition according to any one of claims 1 to 3, where the antibody is a humanized antibody or a human antibody. ! 9. The composition according to any one of claims 1 to 3, additionally containing tryptophan. ! 10. The composition according to any one of claims 1 to 3, having a pH in the range from 4 to 8.! 11. The composition according to any one of claims 1 to 3, where arginine is present in an amount of from 50 to 1500 mm. ! 12. The composition according to any one of claims 1 to 3, having a viscosity of from 2 to 15 MPa · s. ! 13. The composition according to any one of claims 1 to 3, which is stable at 22-28 ° C for at least 6 months. ! 14. The composition according to any one of claims 1 to 3, characterized in that the dimerization of antibody molecules is inhibited. ! 15. The composition according to any one of claims 1 to 3, characterized in that the deamidation of antibody molecules is inhibited. ! 16. The composition according to any one of claims 1 to 3, which is intended for subcutaneous administration. ! 17. The composition according to any one of claims 1 to 3, which did not undergo lyophilization during the preparation of this composition. ! 18. A method of inhibiting the dimerization of antibody molecules in a liqui
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