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    Process for seperating alpha-1-proteinase inhibitor from COHN IV.sub.1 +1V.sub.4 paste
    1.
    发明授权
    Process for seperating alpha-1-proteinase inhibitor from COHN IV.sub.1 +1V.sub.4 paste 失效
    从COHN IV1 + 1V4糊剂中分离α-1蛋白酶抑制剂的方法

    公开(公告)号：US5616693A

    公开(公告)日：1997-04-01

    申请号：US673064

    申请日：1996-07-01

    申请人： Duk S. Hwang ,  Evelyn Nario ,  Mark Lepe ,  Lyndon Luz ,  Hirokazu Ito ,  Kazuo Takechi

    发明人： Duk S. Hwang ,  Evelyn Nario ,  Mark Lepe ,  Lyndon Luz ,  Hirokazu Ito ,  Kazuo Takechi

    IPC分类号： C12N9/64 ,  C07K1/14 ,  C07K14/775 ,  C07K14/81

    CPC分类号： C07K14/775 ,  C07K14/8125 ,  Y10S530/811 ,  Y10S530/812

    摘要： The present invention is directed to a process for purifying alpha-1-PI. The process comprises providing an impure protein fraction which comprises alpha-1-PI. The impure protein fraction is suspended in an aqueous solution at pH 6. Insoluble proteins are recovered and resuspended in aqueous solution at pH 8.5. PEG is added to precipitate .alpha.-2 proteins. To the PEG supernatant precipitation, which comprises alpha-1-PI, is added ZnCl.sub.2 to precipitate crude alpha-1-PI. The crude alpha-1-PI is resolubilized and applied to an anion-exchange medium. A fraction comprising alpha-1-PI is recovered from the anion-exchange medium. Alpha-1-PI purified by the process has a specific activity about 1.0 units/OD.sub.280.

    摘要翻译： 本发明涉及纯化α-1-PI的方法。 该方法包括提供包含α-1-PI的不纯蛋白质级分。 将不纯的蛋白质级分悬浮在pH6的水溶液中。回收不溶性蛋白质并将其重悬于pH8.5的水溶液中。 添加PEG以沉淀α-2蛋白。 向包含α-1-PI的PEG上清液中加入ZnCl 2以沉淀粗α-1-PI。 将粗α-1-PI重新溶解并施用于阴离子交换介质。 从阴离子交换介质中回收包含α-1-PI的级分。 通过该方法纯化的α-1-PI具有约1.0单位/ OD280的比活度。

    Process for increasing the yield of a protein which has been subjected to viral inactivation
    2.
    发明授权
    Process for increasing the yield of a protein which has been subjected to viral inactivation 失效
    增加已进行病毒灭活的蛋白质产量的方法

    公开(公告)号：US5981715A

    公开(公告)日：1999-11-09

    申请号：US829223

    申请日：1997-03-31

    申请人： Duk Sung Hwang ,  Evelyn Nario ,  Mark Lepe ,  Lyndon Luz ,  Hirokazu Ito ,  Kazuo Takechi

    发明人： Duk Sung Hwang ,  Evelyn Nario ,  Mark Lepe ,  Lyndon Luz ,  Hirokazu Ito ,  Kazuo Takechi

    IPC分类号： C12N9/64 ,  C07K1/14 ,  C07K14/775 ,  C07K14/81 ,  A61K35/14 ,  C07K14/00

    CPC分类号： C07K14/775 ,  C07K14/8125 ,  Y10S530/811 ,  Y10S530/812

    摘要： The present invention is directed to a process for purifying alpha-1-PI. The process comprises providing an impure protein fraction which comprises alpha-1-PI. The impure protein fraction is suspended in an aqueous solution at pH 6. Insoluble proteins are recovered and resuspended in aqueous solution at pH 8.5. PEG is added to precipitate .alpha.-2 proteins. To the PEG supernatant precipitation, which comprises alpha-1-PI, is added ZnCl.sub.2 to precipitate crude alpha-1-PI. The crude alpha-1-PI is resolubilized and applied to an anion-exchange medium. A fraction comprising alpha-1-PI is recovered from the anion-exchange medium. Alpha-1-PI purified by the process has a specific activity about 1.0 units/OD.sub.280.

    摘要翻译： 本发明涉及纯化α-1-PI的方法。 该方法包括提供包含α-1-PI的不纯蛋白质级分。 将不纯的蛋白质级分悬浮在pH6的水溶液中。回收不溶性蛋白质并将其重悬于pH8.5的水溶液中。 添加PEG以沉淀α-2蛋白。 向包含α-1-PI的PEG上清液中加入ZnCl 2以沉淀粗α-1-PI。 将粗α-1-PI重新溶解并施用于阴离子交换介质。 从阴离子交换介质中回收包含α-1-PI的级分。 通过该方法纯化的α-1-PI具有约1.0单位/ OD280的比活度。

    Manufacturing method for intraveneously administrable immune globulin and resultant product
    3.
    发明授权
    Manufacturing method for intraveneously administrable immune globulin and resultant product 有权
    静脉注射免疫球蛋白及其产物的制备方法

    公开(公告)号：US6162904A

    公开(公告)日：2000-12-19

    申请号：US421405

    申请日：1999-10-21

    申请人： Raja R. Mamidi ,  Andranik Bagdasarian ,  Gorgonio Canaveral ,  Kazuo Takechi

    发明人： Raja R. Mamidi ,  Andranik Bagdasarian ,  Gorgonio Canaveral ,  Kazuo Takechi

    IPC分类号： C07K16/06 ,  C07K16/00 ,  A61K38/21 ,  C12N7/06

    CPC分类号： C07K16/065 ,  A61K2039/505

    摘要： A process for producing an intravenously-administrable gamma globulin solution substantially free of contaminating viruses by heat treating for viral inactivation and fractionating an impure gamma globulin solution and then treating the purified gamma globulin with a solvent-detergent for further viral inactivation. In a continuous process disclosed herein, partially purified gamma globulin solids is not recovered as an intermediate product during the disclosed process. In the continuous process, the fractionation to obtain a purified gamma globulin solution is carried out without precipitation of the desired gamma globulin.

    摘要翻译： 用于通过热处理用于病毒灭活并分级分离不纯的γ球蛋白溶液，然后用溶剂洗涤剂处理纯化的γ球蛋白以进一步病毒灭活来生产基本上不含污染病毒的静脉内施用的γ球蛋白溶液的方法。 在本文公开的连续方法中，部分纯化的γ球蛋白固体在所公开的方法中不作为中间产物回收。 在连续方法中，获得纯化的γ球蛋白溶液的分级进行而不沉淀所需的γ球蛋白。

    Method of producing immunoglobulin preparations for intravenous injection
    6.
    发明授权
    Method of producing immunoglobulin preparations for intravenous injection 失效
    生产用于静脉注射的免疫抑制素制剂的方法

    公开(公告)号：US5132406A

    公开(公告)日：1992-07-21

    申请号：US348139

    申请日：1989-05-05

    申请人： Yahiro Uemura ,  Katuhiro Uriyu ,  Kazuo Takechi ,  Yutaka Hirao ,  Tadakazu Suyama

    发明人： Yahiro Uemura ,  Katuhiro Uriyu ,  Kazuo Takechi ,  Yutaka Hirao ,  Tadakazu Suyama

    IPC分类号： A61K39/395 ,  A61K38/00 ,  A61L2/00 ,  C07K16/00

    CPC分类号： C07K16/00 ,  A61L2/0023 ,  A61K38/00

    摘要： A method of producing immunoglobulin preparations for intravenous injection which starts with an immunoblobulin-containing fraction and comprises the treatment steps of:(a) treating said fraction with 4-10 weight/volume percent of polyethylene glycol having a molecular weight of 1,000-10,000 under conditions of pH 4-6, ion strength 0.0001-0.1M and temperature 0.degree.-4.degree. C. and recovering the supernatant,(b) treating the supernatant obtained in step (a) with 10-15 weight/volume percent of polyethylene glycol having a molecular weight of 1,000-10,000 under conditions of pH 6-9, ion strength 0.0001-0.1M and temperature 0.degree.-4.degree. C. and recovering the resulting precipitate, and(c) heat-treating, in any desired step, said immunoglobulin in the presence of a stabilizer under conditions sufficient to inactivate contaminant viruses.The preparations obtained according to the invention retain immunoglobulins without substantial inactivation thereof, and are substantially free of such contaminants as anti-human blood group substance antibodies. With contaminant viruses inactivated as a result of the heat treatment, said preparations have good solubility and are sufficiently low in anticomplement activity.

    摘要翻译： 一种生产用于静脉注射的免疫球蛋白制剂的方法，其起始于含免疫球蛋白的级分，并且包括以下处理步骤：（a）用4-10重量/体积％的分子量为1,000-10,000的聚乙二醇处理所述级分， 条件pH 4-6，离子强度0.0001-0.1M，温度0℃-4℃，回收上清液，（b）用10-15重量/体积％聚乙二醇处理步骤（a）中得到的上清液 在pH 6-9，离子强度为0.0001-0.1M，温度为0〜-4℃的条件下分子量为1,000〜10,000，回收所得沉淀物，（c）在任何所需步骤中热处理， 所述免疫球蛋白在足以灭活污染性病毒的条件下在稳定剂存在下进行。 根据本发明获得的制剂保留免疫球蛋白而基本上不灭活，并且基本上不含抗人血型物质抗体等污染物。 随着由于热处理而灭活的污染物病毒，所述制剂具有良好的溶解性并且抗补体活性足够低。