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公开(公告)号：US5399670A
公开(公告)日：1995-03-21
申请号：US54903
申请日：1993-04-29
CPC分类号： C07K14/755 , A61K38/37
摘要： A process for facilitating the reconstitution of lyophilized Factor VIII complex compositions, and compositions of Factor VIII complex, which are readily reconstituted. The process of the present invention comprises providing a purified Factor VIII complex preparations; adding a stabilization agent comprising arginine; lyophilizing the stabilization agent-Factor VIII complex solutions; and reconstituting the lyophilized stabilization agent-Factor VIII complex by contacting it with solvent for less than one minute.
摘要翻译： 促进重组冻干因子VIII复合物组合物的方法，以及易于重构的因子VIII复合物的组合物。 本发明的方法包括提供纯化的因子VIII复合物制剂; 加入包含精氨酸的稳定剂; 冻干稳定剂 - 因子VIII复合物溶液; 并通过使其与溶剂接触少于1分钟来重构冻干稳定剂 - 因子VIII络合物。
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公开(公告)号：US06566504B2
公开(公告)日：2003-05-20
申请号：US09894346
申请日：2001-06-28
IPC分类号： C07K14755
CPC分类号： C07K14/755 , A61L2/0023 , C07K1/32
摘要： A process for inactivating viral contaminants of lyophilized Factor VIII by heat is provided. The process comprises forming a stable complex between the Factor VIII and a cyclodextrin in an aqueous solution. The solution is then lyophilized, and the Factor VIII/cyclodextrin complex is recovered. The lyophilized Factor VIII/cyclodextrin is then heated to 60° C. to inactivate any virus present. The material may then be reconstituted prior to administration to a patient.
摘要翻译： 提供了通过热灭活冻干因子VIII的病毒污染物的方法。 该方法包括在水溶液中形成因子VIII和环糊精之间的稳定复合物。 然后将溶液冻干，回收因子VIII /环糊精复合物。 然后将冻干的因子VIII /环糊精加热至60℃以灭活存在的任何病毒。 然后可以在给予患者之前重建该材料。
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公开(公告)号：US5659017A
公开(公告)日：1997-08-19
申请号：US554724
申请日：1995-11-07
IPC分类号： C07K14/755
CPC分类号： C07K14/755
摘要： A new method for purifying Factor VIII complex from an impure protein fraction, usually cryoprecipitate, is disclosed. The cryoprecipitate is dissolved in a heparin solution. Then Factor VIII complex is initially purified by polyethylene glycol precipitation. The Factor VIII containing supernatant collected after the precipitation is loaded into an anion exchange column that has a quaternary amino ethyl group. The Factor VIII complex is then eluted from the column with a buffer comprising from about 0.14M to about 0.20M CaCl.sub.2. The final step in the purification is to precipitate the Factor VIII complex in the presence of glycine and sodium chloride. The precipitated Factor VIII complex is then reconstituted and stabilized. The reconstituted Factor VIII complex can then be lyophilized and dry heated to obtain a final Factor VIII product.
摘要翻译： 公开了一种从不纯的蛋白质级分（通常是冷沉淀物）中纯化因子VIII复合物的新方法。 将该沉淀物溶于肝素溶液。 然后，因子VIII复合物最初通过聚乙二醇沉淀来纯化。 将沉淀后收集的含有因子VIII的上清液负载到具有季氨基乙基的阴离子交换柱中。 然后用包含约0.14M至约0.20M CaCl 2的缓冲液从柱中洗脱因子VIII复合物。 纯化的最后一步是在甘氨酸和氯化钠存在下沉淀因子VIII配合物。 然后沉淀的因子VIII复合物被重构并稳定。 然后将重构的因子VIII复合物冻干并干燥加热以获得最终因子VIII产物。
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公开(公告)号：US5288853A
公开(公告)日：1994-02-22
申请号：US876410
申请日：1992-04-30
IPC分类号： C07K14/755 , A61K35/14 , C07K13/00
CPC分类号： C07K14/755
摘要： There is provided in accordance with the practice of this invention a process for separating Factor VIII complex from an impure protein fraction containing Factor VIII complex. An aqueous solution of the impure protein fraction containing Factor VIII complex is applied to a heparin-coupled chromatographic medium, to bind the Factor VIII complex to the medium. The Factor VIII is then recovered from the heparin-coupled chromatographic medium by elution with an aqueous solution comprising CaCl.sub.2 and histidine. The recovered Factor VIII is further purified by precipitation with a solution comprising glycine and NaCl, and washing the resultant precipitate with a solution comprising histidine, glycine, and NaCl to provide a Factor VIII complex solution with a specific activity of about 70 to about 150 units/mg.
摘要翻译： 根据本发明的实践提供了将因子VIII复合物与含有因子VIII复合物的不纯蛋白质级分分离的方法。 将含有因子VIII复合物的不纯蛋白质级分的水溶液施用于肝素偶联色谱介质，以将因子VIII复合物与培养基结合。 然后通过用包含CaCl 2和组氨酸的水溶液洗脱从肝素偶联色谱介质中回收因子VIII。 回收的因子VIII通过用包含甘氨酸和NaCl的溶液沉淀进一步纯化，并用包含组氨酸，甘氨酸和NaCl的溶液洗涤所得沉淀物，以提供比活性为约70至约150单位的因子VIII复合物溶液 / mg。
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