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DRUGS ANTIBODIES
专利权人:
БИОТЕСТ АГ (DE)
发明人:
МЕЛЛЕР Вольфганг (DE),РУДНИК Дитер (DE),МАНЕГ Оливер (DE),РОДЕМЕР Михаэль (DE),ГЕРМЕР Маттиас (DE),БРАУН Файт (DE)
申请号:
RU2012149741/15
公开号:
RU2012149741A
申请日:
2011.04.21
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. An antibody preparation suitable for intravenous administration to humans, comprising IgG, IgA and at least 5% IgM antibodies by weight of the total number of antibodies, where the preparation is obtained from human plasma, the antibody preparation having a specific complement activation activity, and where when analyzed with human serum suitable for determining the ability of an antibody preparation to nonspecifically activate complement, the antibody preparation essentially does not form C5a and / or essentially does not form C3a.2. The antibody preparation of claim 1, further comprising more than 5% IgA and more than 40% IgG by weight of the total number of antibodies. An antibody preparation according to claim 1 or 2, containing at least 10% IgM by weight of the total number of antibodies. The antibody preparation according to claim 3, containing at least 15% IgM by weight of the total number of antibodies. The antibody preparation according to claim 1 or 2, wherein the antibody preparation, adjusted to an IgM concentration of 1.72 mg / ml, forms less than 200 ng / ml C5a after 60 minutes of analysis. The antibody preparation according to claim 1 or 2, wherein the antibody preparation, adjusted to an IgM concentration of 1.72 mg / ml, forms less than 6000 ng / ml C3a after 60 minutes of analysis. The antibody preparation according to claim 1 or 2, wherein in the analysis with serum, the preparation of an antibody with human serum forms the same amount of C5a and / or C3a as a separate human serum ± 70% .8. The antibody preparation of claim 1 or 2, wherein the serum analysis to determine that the antibody preparation does not substantially form C5a comprises the steps of: (a) adding an antibody preparation to 100 μl of human serum to obtain a reaction mixture containing 1, 72 mg / ml IgM, and incubating the reaction mixture for 60 min at 37 ° C with constant stirring; (b) obtaining a set of1. Препарат антитела, пригодный для внутривенного введения человеку, со
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