A PROCESS FOR MANUFACTURING FACTOR VIII HAVING AN IMPROVED RATIO OF FVIII:C/FVIII:AG
    81.
    发明申请
    A PROCESS FOR MANUFACTURING FACTOR VIII HAVING AN IMPROVED RATIO OF FVIII:C/FVIII:AG 审中-公开
    具有FVIII改进比例的制剂因子VIII的方法:C / FVIII:AG

    公开(公告)号:US20160340410A1

    公开(公告)日:2016-11-24

    申请号:US15112936

    申请日:2015-01-20

    申请人: OCTAPHARMA AG

    IPC分类号: C07K14/755 C07K1/22

    摘要: A process for manufacturing of a Factor VIII product having a ratio of FVIII:C/FVIII:Ag of at least 0.7 in the Factor VIII product by using chromatography wherein at least one chromatographic step is performed by means of employing; An affinity chromatography resin having an affinity for specifically binding of Factor VIII which is effected by an affinity ligand which is immobilised on the affinity chromatography resin, said affinity ligand is a 13 kD yeast derived Fab antibody fragment directed to the Factor VIII molecule. An anionic chromatography resin. A size exclusion resin. A Factor VIII product obtainable according to the process with a monomer content of >98% for treatment of haemophilia and avoiding formation of inhibitors.

    摘要翻译: 通过使用色谱法制备在因子VIII产物中具有至少0.7的FVIII:C / FVIII:Ag的比例的因子VIII产物的方法,其中至少一个色谱步骤是通过使用进行的; 亲和层析树脂具有对通过固定在亲和层析树脂上的亲和配体进行的因子VIII的特异性结合的亲和力,所述亲和配体是针对因子VIII分子的13kD酵母衍生的Fab抗体片段。 阴离子色谱树脂。 尺寸排阻树脂。 可根据方法获得的因子VIII产物,其单体含量> 98%用于治疗血友病并避免形成抑制剂。

    Process for isolation and purification of a target protein free of prion protein (PrPSC)
    85.
    发明授权
    Process for isolation and purification of a target protein free of prion protein (PrPSC) 有权
    分离和纯化不含朊病毒蛋白(PrPSC)的目标蛋白的方法

    公开(公告)号:US09296799B2

    公开(公告)日:2016-03-29

    申请号:US12733306

    申请日:2008-08-25

    IPC分类号: C07K14/47

    摘要: A process for isolation and purification of a target protein by chromatography wherein the chromatography removes or depletes prions (PrPSC), comprising the steps of contacting a potentially PrPSC contaminated sample comprising a target protein with a multimodal chromatographic material; setting buffer conditions so that the target protein is bound to the multimodal chromatographic material and whereas PrPSC is not binding to the multimodal chromatographic material; followed by elution of the target protein. a process for isolation and purification of a target protein free of prion protein (prpSC).

    摘要翻译: 通过色谱分离和纯化靶蛋白的方法,其中色谱法除去或消除朊病毒(PrPSC),其包括将包含靶蛋白的潜在PrPSC污染样品与多峰色谱材料接触的步骤; 设定缓冲条件,使靶蛋白与多峰色谱材料结合,而PrPSC不与多峰色谱材料结合; 随后洗脱靶蛋白。 用于分离和纯化不含朊病毒蛋白(prpSC)的靶蛋白的方法。

    Method for purification of complement factor H
    86.
    发明授权
    Method for purification of complement factor H 有权
    纯化补体因子H的方法

    公开(公告)号:US08809510B2

    公开(公告)日:2014-08-19

    申请号:US13879283

    申请日:2011-10-13

    摘要: A method for purification of complement Factor H from a complement Factor H containing source such as blood or blood plasma, in particular a caprylate precipitate of a Factor H containing source, which is e.g. obtained by addition of caprylate ions to fractions of blood or plasma, comprising the steps of: a) providing a Factor H containing source, in particular reconstitution of caprylate precipitate to provide a complement Factor H containing solution; b) performing a cation exchange chromatography in particular as first chromatographic step; c) performing an anion exchange chromatography; d) performing a hydroxyl apatite chromatography; e) followed by ultra/diafiltration to obtain a complement Factor H concentrate.

    摘要翻译: 用于从补体因子H纯化补体因子H的方法,所述补体因子H含有血液或血浆中的源,特别是含H因子的来源的辛酸盐沉淀物。 通过向血液或血浆的级分中加入辛酸盐离子获得,包括以下步骤:a)提供含有因子H的来源,特别是辛酸沉淀重构以提供补体因子H的溶液; b)特别是进行阳离子交换层析作为第一色谱步骤; c)进行阴离子交换层析; d)进行羟基磷灰石层析; e),然后进行超/渗滤以获得补体因子H浓缩物。

    METHOD FOR PURIFICATION OF COMPLEMENT FACTOR H

    公开(公告)号:US20130203971A1

    公开(公告)日:2013-08-08

    申请号:US13879283

    申请日:2011-10-13

    IPC分类号: C07K1/36 C07K14/435

    摘要: A method for purification of complement Factor H from a complement Factor H containing source such as blood or blood plasma, in particular a caprylate precipitate of a Factor H containing source, which is e.g. obtained by addition of caprylate ions to fractions of blood or plasma, comprising the steps of: a) providing a Factor H containing source, in particular reconstitution of caprylate precipitate to provide a complement Factor H containing solution; b) performing a cation exchange chromatography in particular as first chromatographic step; c) performing an anion exchange chromatography; d) performing a hydroxyl apatite chromatography; e) followed by ultra/diafiltration to obtain a complement Factor H concentrate.

    LYOPHILISATION TARGETING DEFINED RESIDUAL MOISTURE BY LIMITED DESORPTION ENERGY LEVELS
    90.
    发明申请
    LYOPHILISATION TARGETING DEFINED RESIDUAL MOISTURE BY LIMITED DESORPTION ENERGY LEVELS 失效
    受限制能源水平指定定义的残留水分的LYPLHISISATION

    公开(公告)号:US20130118025A1

    公开(公告)日:2013-05-16

    申请号:US13625482

    申请日:2012-09-24

    IPC分类号: F26B5/06

    CPC分类号: F26B5/06 A61K9/19

    摘要: A process of freeze drying of an essentially aqueous solution comprising at least one first step having a first temperature and pressure level (i.e. primary drying phase) and at least one second step having a second temperature and pressure level (i.e. secondary drying phase) following the first step, wherein in the secondary drying phase limited desorption energy input is applied.

    摘要翻译: 包含至少一个具有第一温度和压力水平的第一步骤(即初级干燥阶段)的基本水溶液的冷冻干燥过程以及具有第二温度和压力水平(即第二干燥阶段)的至少一个第二步骤 第一步骤,其中在二次干燥阶段中施加有限的解吸能量输入。