Intravenous immunoglobulin composition
    23.
    发明申请
    Intravenous immunoglobulin composition 有权
    静脉内免疫球蛋白组成

    公开(公告)号:US20070037170A1

    公开(公告)日:2007-02-15

    申请号:US11201282

    申请日:2005-08-11

    IPC分类号: C12Q1/70 C12Q1/68

    摘要: 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.

    摘要翻译: 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极高滴度的个体; (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,由此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。

    Method of the inactivation of viruses by a solvent-detergent combination and nanofiltration
    24.
    发明授权
    Method of the inactivation of viruses by a solvent-detergent combination and nanofiltration 有权
    通过溶剂 - 洗涤剂组合和纳滤法灭活病毒的方法

    公开(公告)号:US06468733B2

    公开(公告)日:2002-10-22

    申请号:US09843153

    申请日:2001-04-27

    IPC分类号: A01N102

    摘要: The invention concerns a method for elimination of viruses from a biological preparation wherein initially enveloped viruses are eliminated by a solvent-detergent step, then the solvent-detergents are removed by a resin composed of silicon beads and finally the preparation is nanofiltered.

    摘要翻译: 本发明涉及从生物制剂中消除病毒的方法,其中通过溶剂 - 洗涤步骤消除初始包膜的病毒,然后通过由硅珠组成的树脂除去溶剂 - 去污剂,最后制备纳米过滤。

    Gelatin Sponge Comprising an Active Ingredient, Its Preparation and Use
    27.
    发明申请
    Gelatin Sponge Comprising an Active Ingredient, Its Preparation and Use 有权
    明胶海绵包含活性成分,其制备和用途

    公开(公告)号:US20140120151A1

    公开(公告)日:2014-05-01

    申请号:US13847898

    申请日:2013-03-20

    IPC分类号: A61K9/70 A61K38/48

    摘要: The present invention is directed to a method for manufacturing a cross-linked gelatin sponge having a surface by providing a cross-linked gelatin sponge, wetting the surface of the sponge by applying a sufficient amount of liquid comprising a protein or peptide active ingredient, wherein a sufficient amount of liquid is one that retains the flexibility of the sponge even after drying. The sponge is then dried the sponge to obtain a flexible, dry and ready to use cross linked gelatin sponge having a layer of protein or peptide active ingredient on the surface thereof.

    摘要翻译: 本发明涉及通过提供交联明胶海绵来制造具有表面的交联明胶海绵的方法,通过施加足量的包含蛋白质或肽活性成分的液体来润湿海绵的表面,其中 足够量的液体即使在干燥后也保持海绵的柔韧性。 然后将海绵干燥成海绵,以获得在其表面上具有蛋白质或肽活性成分层的柔性,干燥且准备使用的交联明胶海绵。

    Intravenous immunoglobulin composition
    29.
    发明授权
    Intravenous immunoglobulin composition 有权
    静脉内免疫球蛋白组成

    公开(公告)号:US08354249B2

    公开(公告)日:2013-01-15

    申请号:US11201282

    申请日:2005-08-11

    IPC分类号: C12P21/04

    摘要: 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.

    摘要翻译: 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极高滴度的个体; (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,由此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。