ЭНДЬЯ Джеймс Д. (US),ГВИ Шиан К. (US),ЛЮ Цзюнь (US),ШЭНЬ Е (US)
申请号：
RU2011104955/15
公开号：
RU2011104955A
申请日:
2011.02.10
申请国别(地区):
RU
年份:
2012
代理人:
摘要：
1. A stable pharmaceutical composition comprising a monoclonal antibody in histidine-acetate buffer, pH 5.5 to 6.5. ! 2. The composition of claim 1, wherein the pH value ranges from 5.8 to 6.2. ! 3. The composition of claim 1, wherein the concentration of histidine-acetate buffer is between about 1 mM to about 200 mM, including about 10 mM to about 40 mM. ! 4. A composition according to claim 1, wherein the antibody concentration is from about 10 mg / ml to about 250 mg / ml, including from about 20 mg / ml to about 40 mg / ml, including from about 80 mg / ml to about 250 mg / ml. ! 5. The composition of claim 1, further comprising a saccharide including sucrose or trehalose. ! 6. A composition according to claim 5, wherein the concentration of saccharide is from about 10 mM to about 1M, including from about 60 mM to about 250 mM. ! 7. The composition of claim 1, further comprising a surfactant, including polysorbate and including polysorbate-20. ! 8. A composition according to claim 7, wherein the concentration of surfactant is from about 0.0001% to about 1.0%, including from about 0.01% to about 0.1%. ! 9. The composition of claim 1, wherein the monoclonal antibody is a full length antibody, an antibody IgG1, humanized antibody, antibody fragment containing an antigen binding region, Fab-fragment and / or F (ab ') 2 fragment. ! 10. The composition of claim 1 which is sterile. ! 11. The composition of claim 1, wherein the monoclonal antibody binds an antigen selected from the group consisting of HER2, CD20, DR5, BR3, IgE, and VEGF. ! 12. The composition of claim 11, wherein the antigen is sobo1. Стабильная фармацевтическая композиция, содержащая моноклональное антитело в гистидин-ацетатном буфере, pH от 5,5 до 6,5. ! 2. Композиция по п.1, в которой значение pH составляет от 5,8 до 6,2. ! 3. Композиция по п.1, в которой концентрация гистидин-ацетатного буфера составляет от приблизительно 1 мМ до приблизительно 200 мМ, включая от приблизительно 10 мМ до приблизител
