PROCESS FOR THE PURIFICATION OF A GROWTH FACTOR PROTEIN
    62.
    发明申请
    PROCESS FOR THE PURIFICATION OF A GROWTH FACTOR PROTEIN 有权
    净化生长因子蛋白的方法

    公开(公告)号:US20130096279A1

    公开(公告)日:2013-04-18

    申请号:US13638244

    申请日:2011-03-30

    IPC分类号: C07K1/16 C07K1/36

    摘要: A process of purifying a Growth Factor Protein in a purification sequence employing chromatography characterized in that at least one chromatography is performed using a multimodal resin the Growth Factor Protein binds to the multimodal resin at a pH between 4 to 6.2, and the Growth Factor Protein is eluting at a pH>6.3, and the elution of Growth Factor Protein is improved by addition of arginine and/or NaCl to the eluting buffer. The multimodal resin step is followed by a yeast derived affinity ligand resin step, which results of a purity of the product>90%.

    摘要翻译: 在使用色谱纯化的纯化序列中纯化生长因子蛋白的方法,其特征在于使用多峰树脂进行至少一个色谱,生长因子蛋白在4至6.2之间的pH下与多峰树脂结合,并且生长因子蛋白是 在pH> 6.3时洗脱,通过向洗脱缓冲液中加入精氨酸和/或NaCl来改善生长因子蛋白质的洗脱。 多峰树脂步骤之后是酵母衍生的亲和配体树脂步骤,产物的纯度> 90%。

    Method of providing a purified, virus safe antibody preparation
    63.
    发明授权
    Method of providing a purified, virus safe antibody preparation 有权
    提供纯化的病毒安全抗体制剂的方法

    公开(公告)号:US07553938B2

    公开(公告)日:2009-06-30

    申请号:US10590900

    申请日:2005-02-25

    IPC分类号: A61K39/395 C07K1/18 C07K1/34

    摘要: A method of preparing a purified, virus inactivated and virus safe antibody preparation from a starting solution comprising antibodies and contaminants, the method comprising the steps of: (a) adjusting the pH of the starting solution to about 4.6 to about 4.95 in particular to about 4.8 to about 4.95 to produce an intermediate solution; (b) adding caprylate and/or heptanoate ions to the intermediate solution and maintaining the pH at about 4.6 to about 4.95 in particular pH at about 4.8 to about 4.95, whereby a precipitate is formed and the antibodies are essentially present in the supernatant; (c) incubating the supernatant solution under conditions of caprylate and/or heptanoate ion concentration, time, pH and temperature optionally concentrating and diafiltrating the filtrated solution before pH adjustment; (d) applying the filtered solution with a least one anion exchange resin and optionally with two different anion exchange resins under conditions that allow binding of contaminants to the resin while not allowing significant binding' of the antibodies to the resin, wherein a purified, virus inactivated and virus safe antibody preparation is produced.

    摘要翻译: 从包含抗体和污染物的起始溶液制备纯化的病毒灭活和病毒安全的抗体制剂的方法,所述方法包括以下步骤:(a)将起始溶液的pH调节至约4.6至约4.95,特别是约 4.8至约4.95以产生中间溶液; (b)向中间体溶液中加入辛酸酯和/或庚酸酯离子,并将pH保持在约4.6至约4.95,特别是约4.8至约4.95的pH,由此形成沉淀物,并且抗体基本上存在于上清液中; (c)在辛酸盐和/或庚酸盐离子浓度,时间,pH和温度条件下将上清液温育,任选地浓缩并在pH调节之前渗滤滤液; (d)在允许污染物与树脂结合的条件下使用至少一种阴离子交换树脂和任选地含有两种不同的阴离子交换树脂的过滤溶液,同时不允许抗体与树脂的显着结合,其中纯化的病毒 产生灭活和病毒安全的抗体制备。

    Hemostatically active vWF-containing preparation and process for the preparation thereof
    64.
    发明申请
    Hemostatically active vWF-containing preparation and process for the preparation thereof 有权
    含血液活性的含vWF的制剂及其制备方法

    公开(公告)号:US20070232791A1

    公开(公告)日:2007-10-04

    申请号:US11649357

    申请日:2007-01-04

    IPC分类号: C07K14/745 C07K1/22

    CPC分类号: C07K14/755

    摘要: A process for preparing a hemostatically active preparation containing von Willebrand factor (vWF) from a fraction of human plasma by chromatographic purification of a vWF-containing plasma fraction on an anion-exchange material which has the anion-exchanging groups on grafted polymeric structures (tentacle materials), collecting a vWF-containing fraction, followed by purification of said fraction using gel permeation to prepare a purified thermally stable vWF-containing preparation; and heating the preparation for inactivating viruses.

    摘要翻译: 通过在具有接枝聚合物结构上的阴离子交换基团的阴离子交换材料上层析纯化含vWF的血浆级分,从一部分人血浆中制备含有血管性血友病因子(vWF)的止血活性制剂的方法 材料),收集含vWF的级分,然后使用凝胶渗透纯化所述级分以制备纯化的热稳定的含vWF的制剂; 并加热灭活病毒的制剂。

    Method of providing a purified, virus safe antibody preparation
    65.
    发明申请
    Method of providing a purified, virus safe antibody preparation 有权
    提供纯化的病毒安全抗体制剂的方法

    公开(公告)号:US20070173638A1

    公开(公告)日:2007-07-26

    申请号:US10590900

    申请日:2005-02-25

    IPC分类号: C07K16/18

    摘要: A method of preparing a purified, virus inactivated and virus safe antibody preparation from a starting solution comprising antibodies and contaminants, the method comprising the steps of: (a) adjusting the pH of the starting solution to about 4.6 to about 4.95 in particular to about 4.8 to about 4.95 to produce an intermediate solution; (b) adding caprylate and/or heptanoate ions to the intermediate solution and maintaining the pH at about 4.6 to about 4.95 in particular pH at about 4.8 to about 4.95, whereby a precipitate is formed and the antibodies are essentially present in the supernatant; (c) incubating the supernatant solution under conditions of caprylate and/or heptanoate ion concentration, time, pH and temperature optionally concentrating and diafiltrating the filtrated solution before pH adjustment; (d) applying the filtered solution with a least one anion exchange resin and optionally with two different anion exchange resins under conditions that allow binding of contaminants to the resin while not allowing significant binding' of the antibodies to the resin, wherein a purified, virus inactivated and virus safe antibody preparation is produced.

    摘要翻译: 从包含抗体和污染物的起始溶液制备纯化的病毒灭活和病毒安全的抗体制剂的方法,所述方法包括以下步骤:(a)将起始溶液的pH调节至约4.6至约4.95,特别是约 4.8至约4.95以产生中间溶液; (b)向中间体溶液中加入辛酸酯和/或庚酸酯离子,并将pH保持在约4.6至约4.95,特别是约4.8至约4.95的pH,由此形成沉淀物,并且抗体基本上存在于上清液中; (c)在辛酸盐和/或庚酸盐离子浓度,时间,pH和温度条件下将上清液温育,任选地浓缩并在pH调节之前渗滤滤液; (d)在允许污染物与树脂结合的条件下使用至少一种阴离子交换树脂和任选地含有两种不同的阴离子交换树脂的过滤溶液,同时不允许抗体与树脂的显着结合,其中纯化的病毒 产生灭活和病毒安全的抗体制备。

    Process for preparing an alpha-1-antitrypsin solution
    66.
    发明申请
    Process for preparing an alpha-1-antitrypsin solution 审中-公开
    制备α-1-抗胰蛋白酶溶液的方法

    公开(公告)号:US20060194300A1

    公开(公告)日:2006-08-31

    申请号:US10566354

    申请日:2004-08-12

    IPC分类号: C12N9/99

    摘要: A process for preparing A1AT from A1AT-containing solutions, comprising the following steps: (a) subjecting an A1AT-containing solution to ion-exchange chromatography; (b) adding detergents and optionally a solvent for inactivating lipid-enveloped viruses; (c) followed by increasing the salt concentration to salt out the detergents. A1AT having a purity of >90% with an activity of ≧0.8 PEU/mg in its active form.

    摘要翻译: 一种从含有A1AT的溶液制备A1AT的方法,包括以下步骤:(a)使含A1AT的溶液进行离子交换层析; (b)添加去污剂和任选的用于灭活脂质包膜病毒的溶剂; (c),然后增加盐浓度以除去洗涤剂。 纯度为> 90%,活性为> = 0.8 PEU / mg的活性形式的A1AT。

    Method for sterilizing a native collagen in liquid medium, sterile native collagen obtained, compositions containing it and uses
    68.
    发明申请
    Method for sterilizing a native collagen in liquid medium, sterile native collagen obtained, compositions containing it and uses 审中-公开
    在液体培养基中消毒天然胶原蛋白的方法,获得的无菌天然胶原蛋白,含有它的组合物和用途

    公开(公告)号:US20020061842A1

    公开(公告)日:2002-05-23

    申请号:US09917233

    申请日:2001-07-30

    申请人: OCTAPHARMA AG

    发明人: Hamza Mansour

    摘要: The invention concerns a method for preparing native collagen, comprising pretreatment of the collagen in a mixer with double transverse cutters equipped with a system controlling agitating and shearing velocity and a thermostat, and a subsequent step of sterilizing the collagen in liquid medium. The invention also concerns a sterile collagen, in particular a collagen mostly of type I, in native state and in particular pharmaceutical and/or parapharmaceutical and/or medico-surgical and/or ophthalmologic and/or cosmetic compositions and applications thereof.

    摘要翻译: 本发明涉及一种制备天然胶原蛋白的方法,包括在配备有控制搅动和剪切速度的系统的双横切割机和恒温器的混合器中对胶原蛋白进行预处理,以及随后在液体培养基中对胶原进行灭菌的步骤。 本发明还涉及无菌胶原,特别是天然状态的特别是I型的胶原,特别是药物和/或副药物和/或医学外科和/或眼科和/或化妆品组合物和应用。

    Process for testing suitability of protein fractions containing factor
VIII
    69.
    发明授权
    Process for testing suitability of protein fractions containing factor VIII 有权
    测试含有因子VIII的蛋白质级分适合性的方法

    公开(公告)号:US6057164A

    公开(公告)日:2000-05-02

    申请号:US142384

    申请日:1999-01-07

    摘要: The method for the aptitude testing of protein fractions containing factor VIII the further processing of which comprises a pasteurizing step is performed in such a way that the starting material is examined for fragments within a range of from 20 to 50 kD. Fragments of factor VIII within this range evidently cause inhibitor formations in patients pretreated with factor VIII. Batches contaminated with such fragments can also be utilized, i.e., for the preparation of a high purity virus-free factor VIII by size exclusion chromatography on hydrophilic materials.

    摘要翻译: PCT No.PCT / EP97 / 00703 Sec。 一九九九年一月七日 102(e)1999年1月7日PCT 1997年3月1日PCT公布。 出版物WO97 / 33178 日期1997年9月12日对含有因子VIII的蛋白质级分进行能力测试的方法,其进一步处理包括巴氏灭菌步骤的方法是使起始材料被检查为20至50kD范围内的片段。 在此范围内因子VIII的片段在用因子VIII预处理的患者中显然引起抑制剂形成。 也可以利用被这种片段污染的批次,即用于通过亲水材料上的尺寸排阻色谱法制备高纯度无病毒因子VIII。