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STABLE COMPOSITIONS WITH HIGH PROTEIN CONCENTRATIONS OF HUMAN ANTIBODIES AGAINST TNF-ALPHA
专利权人:
ЭББОТТ БАЙОТЕКНОЛОДЖИ ЛТД. (BM)
发明人:
ФРАУНХОФЕР Вольфганг (US),КРАУЗЕ Ханс-Юрген (DE),НОЙ Михаэль (DE)
申请号:
RU2011149327/15
公开号:
RU2011149327A
申请日:
2010.05.03
申请国别(地区):
RU
年份:
2013
代理人:
摘要:
1. A liquid pharmaceutical composition comprising more than about 20 mg of a polyol and at least about 100 mg / ml of a human antibody against TNF-alpha, or its antigennegative part, which includes a light chain comprising a CDR3 region comprising the amino acid sequence represented as SEQ ID NO: 3 or resulting from a modification of SEQ ID NO: 3 by one substitution for alanine at position 1, 4, 5, 7 or 8, or by one to five conservative amino acid substitutions at positions 1, 3, 4, 6, 7, 8 and / or 9, and the heavy chain, including comprising a CDR3 region comprising the amino acid sequence represented as SEQ ID NO: 4 or resulting from the modification of SEQ ID NO: 4 by one substitution for alanine at position 2, 3, 4, 5, 6, 8, 9, 10, or 11, or by one to five conservative amino acid substitutions at positions 2, 3, 4, 5, 6, 8, 9, 10, 11 and / or 12, the composition not containing a NaCl filler. 2. A composition according to claim 1, which comprises more than about 30 mg of a polyol. A composition according to claim 1, which comprises more than about 40 mg of a polyol. A composition according to claim 1, which comprises approximately 40-45 mg of a polyol. A composition according to any one of claims 1 to 4, wherein the polyol is a sugar alcohol. The composition of claim 5, wherein the sugar alcohol is mannitol or sorbitol. The composition of claim 1, wherein the human antibody is IgG1 kappa human antibody. The composition of claim 1, wherein the light chain of the human antibody y further comprises a CDR2 region comprising the amino acid sequence represented by SEQ ID NO: 5 and a CDR1 region comprising the amino acid sequence represented by SEQ ID NO: 7 , and / or heavy chain of a human antibody1. Жидкая фармацевтическая композиция, включающая более чем приблизительно 20 мг полиола и по крайней мере приблизительно 100 мг/мл антитела человека против TNF-альфа, или его антигенсвязывающей части, которое включает легкую цепь, включающую CDR3-участок, включающий аминоки
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