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1. 发明申请

WO2008116103A3 STABLE ANTIBODY FORMULATIONS 审中-公开
标题翻译：稳定的抗体制剂
公开(公告)号：WO2008116103A3
公开(公告)日：2009-01-08
申请号：PCT/US2008057718
申请日：2008-03-20
申请人： IMCLONE SYSTEMS INC , SRIVASTAVA ARVIND , GOLDSTEIN JOEL
发明人： SRIVASTAVA ARVIND , GOLDSTEIN JOEL
IPC分类号： A61K39/395 , C07K16/00
CPC分类号： A61K39/39591 , C07K16/2863
摘要： The present invention provides formulations and methods for the stabilization of antibodies. In one embodiment, the invention provides the stable solution formulation of an IgG1 antibody that specifically binds to insulin-like growth factor-I receptor. In another embodiment, the invention provides methods of stabilization of IgG1 antibody that specifically binds to insulin-like growth factor-I receptor comprising lyophilizing an aqueous formulation of the antibody. The formulations can be lyophilized to stabilize the antibodies during processing and storage, and then the formulations can be reconstituted for pharmaceutical administration.
摘要翻译：本发明提供用于稳定抗体的制剂和方法。在一个实施方案中，本发明提供了与胰岛素样生长因子-I受体特异性结合的IgG1抗体的稳定溶液制剂。在另一个实施方案中，本发明提供了特异性结合胰岛素样生长因子-I受体的IgG1抗体的稳定化方法，其包括将抗体的水性制剂冻干。制剂可以在加工和储存期间被冻干以稳定抗体，然后可以将制剂重新配制用于药物施用。

2. 发明申请

WO2007095337A3 ANTIBODY FORMULATION 审中-公开
标题翻译：抗体配方
公开(公告)号：WO2007095337A3
公开(公告)日：2008-11-27
申请号：PCT/US2007004050
申请日：2007-02-15
申请人： IMCLONE SYSTEMS INC , GOLDSTEIN JOEL , SRIVASTAVA ARVIND
发明人： GOLDSTEIN JOEL , SRIVASTAVA ARVIND
IPC分类号： A61K39/00 , A61K39/395
CPC分类号： C07K16/2863 , A61K9/0019 , A61K9/19 , A61K39/39591
摘要： The present invention provides formulations and methods for the stabilization of antibodies. In one embodiment, the invention provides the stabile formulation of antibodies that are prone to non-enzymatic fragmentation at the hinge region. In a further embodiment, the invention provides methods of stabilization of antibodies comprising lyophilizing an aqueous formulation of an antibody. The formulations can be lyophilized to stabilize the antibodies during processing and storage, and then the formulations can be reconstituted for pharmaceutical administration. In one embodiment, the present invention provides methods of stabilization of anti- VEGFR antibodies comprising lyophilizing an aqueous formulation of an anti-VEGFR antibody. The formulations can be lyophilized to stabilize the ahti-VEGFR antibodies during processing and storage, and then the formulations can be reconstituted for pharmaceutical administration.
摘要翻译：本发明提供用于稳定抗体的制剂和方法。在一个实施方案中，本发明提供了在铰链区域易于非酶促断裂的抗体的稳定制剂。在另一个实施方案中，本发明提供了稳定抗体的方法，其包括将抗体的水性制剂冻干。制剂可以在加工和储存期间被冻干以稳定抗体，然后可以将制剂重新配制用于药物施用。在一个实施方案中，本发明提供抗VEGFR抗体的稳定化方法，其包括将抗VEGFR抗体的水性制剂冻干。制剂可以在加工和储存期间被冻干以稳定ahti-VEGFR抗体，然后可以将制剂重新配制用于药物施用。

3. 发明申请

WO2007147001A3 LYOPHILIZED FORMULATIONS OF ANTI-EGFR ANTIBODIES 审中-公开
标题翻译：抗EGFR抗体的LYOPHILIZING制剂
公开(公告)号：WO2007147001A3
公开(公告)日：2008-07-10
申请号：PCT/US2007071119
申请日：2007-06-13
申请人： IMCLONE SYSTEMS INC , AGARKHED MEERA , SRIVASTAVA ARVIND , GOLDSTEIN JOEL
发明人： AGARKHED MEERA , SRIVASTAVA ARVIND , GOLDSTEIN JOEL
IPC分类号： A61K39/00
CPC分类号： A61K39/39591 , A61K31/7012 , C07K16/2863 , C07K2317/24
摘要： In one embodiment, the present invention provides a stable lyophilized formulation comprising an anti-EGFR antibody, preferably cetuximab; lactobionic acid; and a buffer, preferably histidine. In one preferred embodiment, the present invention provides a stable lyophilized formulation comprising about 50 mg/mL to about 140 mg/mL of ERBITUX?, about 0.125% lactobionic acid, about 25 mM histidine buffer at a pH of about 6.0, about 0.005% Tween 80, and about 1.875% glycine.
摘要翻译：在一个实施方案中，本发明提供了包含抗EGFR抗体，优选西妥昔单抗的稳定的冻干制剂; 乳糖酸和缓冲液，优选组氨酸。在一个优选的实施方案中，本发明提供了稳定的冻干制剂，其包含约50mg / mL至约140mg / mL的ERBITUXα，约0.125％的乳糖酸，约25mM组氨酸缓冲液，pH约6.0，约0.005％吐温80和约1.875％甘氨酸。

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