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COMPOSITIONS OF ANTIBODIES AGAINST NERVE GROWTH FACTOR (NGF)
专利权人:
ЭББОТТ РИСЕРЧ Б.В. (NL)
发明人:
ФРАУНХОФЕР Вольфганг (US),ЧАРИ Рави (US),КУМАР Винеет (US),ЗЕДЛЕР Райнер (DE),ЗИДЛЕР Михель (US),СТАЙН Улльям Б. (US),ВЕБЕР Карстен (DE)
申请号:
RU2012144017/10
公开号:
RU2012144017A
申请日:
2011.03.16
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A pharmaceutical composition comprising: (a) an antibody against nerve growth factor (NGF) or an antigen binding fragment thereof comprising (i) a heavy chain variable region comprising CDR 1, 2 and 3 having the amino acid sequences of SEQ ID NO: 3, 4 and 5, respectively, (ii) the variable region of the light chain containing CDR 1, 2 and 3 having the amino acid sequences of SEQ ID NO: 6, 7 and 8, respectively, and (iii) the constant region of human IgG4 having the amino acid sequence of SEQ ID NO: 10, wherein the concentration of the antibody or antigen binding fragment thereof a is from about 10 to about 50 mg / ml; (b) a histidine buffer at a concentration of from about 10 to about 30 mM histidine; and (c) Polysorbate 80 at a concentration of from about 0.01 to about 0.02%; wherein the pH of the composition is from about 5.0 to about 6.0.2. The pharmaceutical composition of claim 1, wherein said anti-nerve growth factor (NGF) antibody comprises a human IgG4 constant region having the sequence of SEQ ID NO: 10, where the antibody contains a heavy chain with the amino acid sequence of SEQ ID NO: 13 and a light chain with the amino acid sequence SEQ ID NO: 16, wherein the concentration of the antibody or antigen binding fragment thereof is from about 10 to about 50 mg / ml. 3. The pharmaceutical composition according to claim 1, which further comprises from about 10 to about 50 mg / ml mannitol. The pharmaceutical composition according to claim 1, which further comprises from about 5 to about 70 mg / ml sucrose. The pharmaceutical composition according to claim 1, which further comprises from1. Фармацевтическая композиция, содержащая:(a) антитело против фактора роста нервов (NGF) или его антигенсвязующий фрагмент, содержащее (i) вариабельную область тяжелой цепи, содержащую CDR 1, 2 и 3, имеющие аминокислотные последовательности SEQ ID NO:3, 4 и 5 соответственно, (ii) вариабельную область легкой цепи, содержащую CDR 1, 2 и 3, имеющие аминокислотные последовательн
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