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公开(公告)号:EP0345543A2
公开(公告)日:1989-12-13
申请号:EP89109372.6
申请日:1989-05-24
申请人: MILES INC.
IPC分类号: A61K39/395
CPC分类号: C07K16/1203 , A61K38/00
摘要: Protective antibody compositions comprising at least 33% by weight of antibodies of the IgM type and substantially free of homologous isoagglutinins are highly active against gram negative pathogens in mammals. Such compositions are preferably polyclonal and prepared from human plasma, or may be a formulation of different monoclonal antibodies. A very preferred IgM content is at least 50% by weight and the isoagglutinin titer is less than about 1:4. In one embodiment, the compositions are prepared in a lyophilized form such that, upon aqueous reconstitution, they result in a solution having a pH ranging from about 4.0 to 8.0, preferably 4.0 to 7.0 and can be administered intravenously.
摘要翻译: 包含至少33重量%的IgM型抗体并基本上不含同源异凝集素的保护性抗体组合物对哺乳动物中的革兰氏阴性病原体具有高度活性。 这样的组合物优选为多克隆并由人血浆制备,或可以是不同单克隆抗体的制剂。 非常优选的IgM含量为至少50重量%,异凝集素滴度小于约1:4。 在一个实施方案中,组合物以冻干形式制备,使得在水重构时,它们产生pH范围为约4.0至8.0,优选4.0至7.0的溶液,并且可以静脉内施用。
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公开(公告)号:EP0321835A2
公开(公告)日:1989-06-28
申请号:EP88120808.6
申请日:1988-12-13
申请人: MILES INC.
IPC分类号: C07K3/12
CPC分类号: C07K14/755
摘要: Highly purified antihemophilic factor is produced by a process comprising a PEG precipitation step, a gel filtration step and a virus inactivation step. Al(OH)₃ adsorption and PEG precipitation carried out at room temperature allow processing to proceed directly to a gel filtration step.
摘要翻译: 通过包括PEG沉淀步骤,凝胶过滤步骤和病毒灭活步骤的方法产生高度纯化的抗血友病因子。 Al(OH)3吸附和在室温下进行的PEG沉淀使加工直接进行凝胶过滤步骤。
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公开(公告)号:EP0345543B1
公开(公告)日:1994-10-12
申请号:EP89109372.6
申请日:1989-05-24
申请人: MILES INC.
IPC分类号: A61K39/395
CPC分类号: C07K16/1203 , A61K38/00
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公开(公告)号:EP0399321B1
公开(公告)日:1993-06-23
申请号:EP90108993.8
申请日:1990-05-12
申请人: MILES INC.
IPC分类号: A61K35/16
CPC分类号: C07K14/755 , A61K38/00
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公开(公告)号:EP0374625B1
公开(公告)日:1992-11-19
申请号:EP89122657.3
申请日:1989-12-08
申请人: MILES INC.
CPC分类号: A61L2/0088 , Y10S424/808 , Y10S530/865
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公开(公告)号:EP0399321A3
公开(公告)日:1991-07-17
申请号:EP90108993.8
申请日:1990-05-12
申请人: MILES INC.
IPC分类号: A61K35/16
CPC分类号: C07K14/755 , A61K38/00
摘要: Highly purified antihemophilic factor is produced by a process comprising a PEG precipitation step, a gel filtration step and a heat treating virus inactivation step. Al(OH)₃ adsorption and PEG precipitation carried out at room temperature allow processing to proceed directly to a gel filtration step.
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公开(公告)号:EP0345543A3
公开(公告)日:1990-06-13
申请号:EP89109372.6
申请日:1989-05-24
申请人: MILES INC.
IPC分类号: A61K39/395
CPC分类号: C07K16/1203 , A61K38/00
摘要: Protective antibody compositions comprising at least 33% by weight of antibodies of the IgM type and substantially free of homologous isoagglutinins are highly active against gram negative pathogens in mammals. Such compositions are preferably polyclonal and prepared from human plasma, or may be a formulation of different monoclonal antibodies. A very preferred IgM content is at least 50% by weight and the isoagglutinin titer is less than about 1:4. In one embodiment, the compositions are prepared in a lyophilized form such that, upon aqueous reconstitution, they result in a solution having a pH ranging from about 4.0 to 8.0, preferably 4.0 to 7.0 and can be administered intravenously.
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公开(公告)号:EP0321835B1
公开(公告)日:1994-09-28
申请号:EP88120808.6
申请日:1988-12-13
申请人: MILES INC.
IPC分类号: C07K3/12
CPC分类号: C07K14/755
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9.
公开(公告)号:EP0399321A2
公开(公告)日:1990-11-28
申请号:EP90108993.8
申请日:1990-05-12
申请人: MILES INC.
IPC分类号: A61K35/16
CPC分类号: C07K14/755 , A61K38/00
摘要: Highly purified antihemophilic factor is produced by a process comprising a PEG precipitation step, a gel filtration step and a heat treating virus inactivation step. Al(OH)₃ adsorption and PEG precipitation carried out at room temperature allow processing to proceed directly to a gel filtration step.
摘要翻译: 通过包括PEG沉淀步骤,凝胶过滤步骤和热处理病毒灭活步骤的方法产生高度纯化的抗血友病因子。 Al(OH)3吸附和在室温下进行的PEG沉淀使加工直接进行凝胶过滤步骤。
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公开(公告)号:EP0374625A2
公开(公告)日:1990-06-27
申请号:EP89122657.3
申请日:1989-12-08
申请人: MILES INC.
CPC分类号: A61L2/0088 , Y10S424/808 , Y10S530/865
摘要: Lipid-enveloped viruses present in purified biologically active protein products obtained from blood or cell culture systems can be inactivated by contacting the products with caprylic acid at a non-ionized concentration, pH, temperature and ionic environment sufficient to inactivate the viruses without adversely precipitating or affecting the biological activity of the protein products.
摘要翻译: 存在于从血液或细胞培养系统获得的纯化的生物活性蛋白质产物中的脂质包膜病毒可以通过使产物与非离子浓度,pH,温度和离子环境的辛酸接触而灭活,足以灭活病毒而不会不利地沉淀或 影响蛋白质产品的生物活性。
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