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    • 3. 发明申请
    • INTRAVENOUS IMMUNOGLOBULIN COMPOSITION
    • 无菌免疫组织化学
    • WO2007017859A1
    • 2007-02-15
    • PCT/IL2006/000782
    • 2006-07-06
    • OMRIX BIOPHARMACEUTICALS INC.NUR, IsraelBAR, LilianaLAUB, Orgad
    • NUR, IsraelBAR, LilianaLAUB, Orgad
    • C07K16/08A61K39/395A61P31/12
    • C07K16/081A61K38/00A61K39/39591A61K2039/505C07K2319/00
    • A method for preparing a concentrated, immunoglobulin composition for treating subjects vaccinated against or infected with a pathogenic microorganism, comprising: (a) selecting a population of individuals previously vaccinated against one or more antigens associated with the pathogenic microorganism; (b) determining the level of specific antibodies immunoreactive with the pathogenic microorganism in a blood or blood component of the individuals to identify very high titre individuals having a very high titre of the specific antibodies; (c) combining blood or blood components comprising immunoglobulins from the very high titre individuals; and (d) purifying and/or concentrating the product of step (c), thereby obtaining a concentrated immunoglobulin composition. Also disclosed is a concentrated immunoglobulin composition comprising specific antibodies immunoreactive with a pathogenic microorganism, characterized in that the titre of specific antibodies of the composition is at least 5 times higher than the average titre of specific antibodies of a population of individuals previously vaccinated against one or more antigens associated with the pathogenic microorganism. The composition has a relatively high protein concentration and a low percentage of protein aggregates, and is therefore suitable for both iv and im administration. In a preferred embodiment, the pathogenic microorganism is smallpox virus or vaccinia virus.
    • 一种制备用于治疗接种疫苗或感染病原微生物的受试者的浓缩免疫球蛋白组合物的方法,包括:(a)选择先前针对与病原微生物相关的一种或多种抗原接种的个体群体; (b)确定在个体的血液或血液成分中与病原微生物免疫反应的特异性抗体的水平,以鉴定具有非常高的特异性抗体滴度的非常高的滴度个体; (c)从非常高的滴度个体组合包含免疫球蛋白的血液或血液成分; 和(d)纯化和/或浓缩步骤(c)的产物,从而获得浓缩的免疫球蛋白组合物。 还公开了包含与病原微生物免疫反应性的特异性抗体的浓缩免疫球蛋白组合物,其特征在于组合物的特异性抗体滴度比先前接种于一种或多种疫苗的个体群体的特异性抗体的平均滴度高至少5倍 更多与病原微生物相关的抗原。 该组合物具有相对高的蛋白质浓度和低百分比的蛋白质聚集体,因此适用于iv和im施用。 在优选的实施方案中,致病微生物是天花病毒或痘苗病毒。