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    Stable transglutaminase preparations and processes for their production
    1.
    发明授权
    Stable transglutaminase preparations and processes for their production 失效
    稳定的转谷氨酰胺酶制剂及其生产工艺

    公开(公告)号：US06204036B1

    公开(公告)日：2001-03-20

    申请号：US08999702

    申请日：1997-12-22

    申请人： Hubert Metzner ,  Hermann Karges

    发明人： Hubert Metzner ,  Hermann Karges

    IPC分类号： C12N996

    CPC分类号： C12N9/1044 ,  A61K38/45

    摘要： The present invention relates to stable preparation forms of a transglutaminase, for example factor XIII, which, after lyophilization, are readily soluble without turbidity. The preparation froms comprise, in addition to the transglutaminase additives selected from the group consisting of D- and/or L-amino acids other than glycine and arginine, their salts, derivatives and homologs, or dimers or oligomers thereof or mixtures thereof, and sugars or sugar alcohols. The formulations may also comprise surface active agents and/or reducing agents. The invention provides processes for preparing stable protein preparations and to the use of the described stable preparation forms for producing pharmaceuticals which are suitable, for example, for treating diseases which are characterized by F XIII deficiency.

    摘要翻译： 本发明涉及转谷氨酰胺酶的稳定制备形式，例如因子XIII，其在冻干后容易溶解而无浊度。 除了甘氨酸和精氨酸以外的选自D-和/或L-氨基酸的转谷氨酰胺酶的添加剂，其制剂还包含其盐，衍生物和同系物或其二聚体或其低聚物或其混合物和糖 或糖醇。 制剂还可以包含表面活性剂和/或还原剂。 本发明提供了制备稳定的蛋白质制剂的方法以及所述稳定的制剂形式用于生产药物的用途，所述药物适用于例如用于治疗以F XIII缺陷为特征的疾病。

    Proteolytically cleavable fusion proteins with high molar specific activity
    3.
    发明申请
    Proteolytically cleavable fusion proteins with high molar specific activity 审中-公开
    具有高摩尔比活性的蛋白水解切割融合蛋白

    公开(公告)号：US20090042787A1

    公开(公告)日：2009-02-12

    申请号：US11812016

    申请日：2007-06-14

    申请人： Hubert Metzner ,  Thomas Weimer ,  Stefan Schulte

    发明人： Hubert Metzner ,  Thomas Weimer ,  Stefan Schulte

    IPC分类号： A61K38/16 ,  C07K19/00 ,  C07H21/04 ,  C12N15/63 ,  A61P7/00 ,  A61K31/711 ,  C12N5/10 ,  C12P21/00

    CPC分类号： C07K14/745 ,  A61K38/00 ,  C07K14/755 ,  C07K2319/31 ,  C12N9/6424 ,  C12N9/6472

    摘要： The invention relates to therapeutic fusion proteins in which a coagulation factor is fused to a half-life enhancing polypeptide, and in which both are connected by a linker peptide that is proteolytically cleavable. The cleavage of such linkers liberates the coagulation factor from activity-compromising steric hindrance caused by the half-life enhancing polypeptide and thereby allows the generation of fusion proteins may show relatively high molar specific activity when tested in coagulation-related assays. Furthermore, the fact that the linker is cleavable can enhance the rates of inactivation and/or elimination after proteolytic cleavage of the peptide linker compared to the rates measured for corresponding therapeutic fusion proteins linked by the non-cleavable linker having the amino acid sequence GGGGGGV (SEQ ID NO: 94).

    摘要翻译： 本发明涉及治疗融合蛋白，其中凝血因子与半衰期增强多肽融合，并且其中两者通过可蛋白水解切割的接头肽连接。 这种接头的切割将凝血因子从半衰期增强多肽引起的活性损害的空间位阻释放，从而允许融合蛋白的产生在凝血相关测定中测试时可显示相对高的摩尔比活性。 此外，与通过具有氨基酸序列GGGGGGV的不可切割接头连接的相应治疗性融合蛋白的测量速率相比，接头可切割的事实可增加肽接头的蛋白水解切割后的失活和/或消除速率（ SEQ ID NO：94）。

    Method for differentiating between factor XIII deficiency states and fibrinogen deficiency states by means of thrombelastographic techniques
    5.
    发明授权
    Method for differentiating between factor XIII deficiency states and fibrinogen deficiency states by means of thrombelastographic techniques 有权
    通过血栓形成技术区分因子XIII缺陷状态和纤维蛋白原缺乏状态的方法

    公开(公告)号：US07939288B2

    公开(公告)日：2011-05-10

    申请号：US11883916

    申请日：2006-02-06

    申请人： Erhardt Wrabetz ,  Hubert Metzner ,  Wolfgang Korte

    发明人： Erhardt Wrabetz ,  Hubert Metzner ,  Wolfgang Korte

    IPC分类号： C12Q1/56

    CPC分类号： G01N33/86 ,  C12Q1/56

    摘要： The invention relates to a method for determining a factor XIII deficiency, a method for determining a fibrinogen deficiency, and a method for differentiating between a factor XIII deficiency and a fibrinogen deficiency by means of thrombelastographic techniques. On the basis of the evaluation of the thrombelastographic parameters, a rapid and a selective substitution of factor XIII and/or of fibrinogen in deficiency states is possible.

    摘要翻译： 本发明涉及一种确定因子XIII缺乏症的方法，一种测定纤维蛋白原缺乏症的方法，以及通过血栓形成技术区分因子XIII缺陷和纤维蛋白原缺乏症的方法。 在评估血栓形成参数的基础上，在缺陷状态下快速和选择性地替代因子XIII和/或纤维蛋白原是可能的。

    Stabilized protein preparations for a tissue adhesive
    6.
    发明授权
    Stabilized protein preparations for a tissue adhesive 有权
    用于组织粘合剂的稳定化蛋白质制剂

    公开(公告)号：US06447774B1

    公开(公告)日：2002-09-10

    申请号：US09856195

    申请日：2001-07-13

    申请人： Hubert Metzner ,  Peter Gronski

    发明人： Hubert Metzner ,  Peter Gronski

    IPC分类号： A61K3848

    CPC分类号： A61L24/106

    摘要： A tissue adhesive is described, which contains three separate components, i.e., a stabilized, essentially fibrinogen-free protein preparation that is of storage-quality in liquid state and contains the blood coagulation factor XIII a stabilized protein preparation that is of storage-quality in liquid state and contains fibrinogen. A chaotropic substance of less than 0.28 mol/liter was added to said protein preparation to avoid or reduce the aggregation of fibrinogen, and a preparation containing thrombin, which are provided in one packaging unit prepared to be used together. Furthermore, stabilized, frozen or lyophilized protein preparations containing fibrinogen and Factor XIII are described. Said protein preparations contain fibrinogen- and Factor XIII which remains stable for more than four weeks after defrosting or reconstitution, as well as one or more added chaotropic substances in a quantity of less than 0.28 mol/liter which prevents or reduces the aggregation of fibrinogen and contain inorganic salts of

    摘要翻译： 描述了一种组织粘合剂，其包含三种独立的组分，即稳定的，基本上不含纤维蛋白原的蛋白质制剂，其在液态下具有储存质量，并且含有液体储存品质的凝血因子XIIIa稳定的蛋白质制剂 状态并含有纤维蛋白原。 向所述蛋白质制剂中加入小于0.28mol /升的离液物质，以避免或减少纤维蛋白原和含有凝血酶的制剂的聚集，所述制剂设置在一起制备用于一起的包装单元中。此外，稳定，冷冻或冻干 描述了含有纤维蛋白原和因子XIII的蛋白质制剂。 所述蛋白质制剂含有纤维蛋白原和因子XIII，其在除霜或重构后保持稳定超过四周，以及一种或多种以小于0.28mol / l的量添加的离液序列物质，其防止或减少纤维蛋白原和 含有<100mmol /升，优选<50mmol /升的无机盐。

    Thrombin preparations and process for their production
    8.
    发明授权
    Thrombin preparations and process for their production 有权
    凝血酶制剂及其生产工艺

    公开(公告)号：US08012728B2

    公开(公告)日：2011-09-06

    申请号：US11385713

    申请日：2006-03-22

    申请人： Hubert Metzner ,  Heinrich Scheider

    发明人： Hubert Metzner ,  Heinrich Scheider

    IPC分类号： C12N9/00

    CPC分类号： A61L24/108 ,  A61K38/4833 ,  A61K47/02 ,  A61K47/183 ,  A61K47/26 ,  A61L24/043 ,  A61L24/106 ,  C08L89/00

    摘要： The production of a thrombin preparation which is obtained from prothrombin which is, after activation to thrombin without the addition of thromboplastin, purified by a hydrophobic interaction chromatography, it being possible subsequently also to inactivate or remove viruses, is described. Before or after the hydrophobic interaction chromatography it is also possible in addition to carry out a cation exchange chromatography. A thrombin preparation which contains as stabilizer a noncovalently binding inhibitor and to which further stabilizers can be added for stabilization in the liquid state is additionally described.

    摘要翻译： 描述了从凝血酶原获得的凝血酶制剂的制备，其在通过疏水相互作用色谱法纯化的活化凝血酶而不加入凝血激酶之后，随后也可以灭活或除去病毒。 在疏水相互作用层析之前或之后，除了进行阳离子交换层析之外，还可以进行。 另外描述了一种凝血酶制剂，其包含作为稳定剂的非共价结合抑制剂，并且可以加入其它稳定剂以稳定液体状态。

    MODIFIED COAGULATION FACTORS WITH PROLONGED IN VIVO HALF-LIFE
    9.
    发明申请
    MODIFIED COAGULATION FACTORS WITH PROLONGED IN VIVO HALF-LIFE 有权
    改良的凝血因子与生殖健康生活息息相关

    公开(公告)号：US20100120664A1

    公开(公告)日：2010-05-13

    申请号：US12520840

    申请日：2007-12-21

    申请人： Stefan Schulte ,  Thomas Weimer ,  Hubert Metzner

    发明人： Stefan Schulte ,  Thomas Weimer ,  Hubert Metzner

    IPC分类号： A61K38/16 ,  C07K14/745 ,  C07K14/755 ,  C07H21/00 ,  C12N15/74 ,  C12N5/10 ,  C12P21/00 ,  A61P7/04

    CPC分类号： C07K14/755 ,  C07K14/745 ,  C07K14/765 ,  C07K16/18 ,  C07K2319/31

    摘要： The present invention relates to nucleic acid sequences coding for modified coagulation factors, preferably coagulation factor VIII, and their derivatives; recombinant expression vectors containing such nucleic acid sequences; host cells transformed with such recombinant expression vectors; and recombinant polypeptides and derivatives coded for by said nucleic acid sequences, whereby said recombinant polypeptides and derivatives have biological activities and prolonged in vivo half-lives compared to the unmodified wild-type proteins. The invention also relates to corresponding sequences that result in improved in vitro stability. The present invention further relates to processes for the manufacture of such recombinant proteins and their derivatives. The invention also relates to a transfer vector for use in human gene therapy, which comprises such nucleic acid sequences.

    摘要翻译： 本发明涉及编码改性凝血因子，优选凝血因子VIII及其衍生物的核酸序列; 含有该核酸序列的重组表达载体; 用这些重组表达载体转化的宿主细胞; 和由所述核酸序列编码的重组多肽和衍生物，其中与未修饰的野生型蛋白相比，所述重组多肽和衍生物具有生物学活性和延长的体内半衰期。 本发明还涉及导致体外稳定性改善的相应序列。 本发明还涉及制备这些重组蛋白及其衍生物的方法。 本发明还涉及用于人基因治疗的转移载体，其包含这样的核酸序列。

    Fibrinogen purification
    10.
    发明授权
    Fibrinogen purification 有权
    纤维蛋白原净化

    公开(公告)号：US07550567B2

    公开(公告)日：2009-06-23

    申请号：US11062432

    申请日：2005-02-23

    申请人： Hubert Metzner ,  Uwe Liebing ,  Annette Feussner ,  Joerg Lemmer ,  Stefan Schulte ,  Volker Gawantka

    发明人： Hubert Metzner ,  Uwe Liebing ,  Annette Feussner ,  Joerg Lemmer ,  Stefan Schulte ,  Volker Gawantka

    IPC分类号： C07K14/75 ,  C07K1/16

    CPC分类号： C07K14/75

    摘要： The present invention relates to a process for purifying fibrinogen, which comprises one or more process steps in which one or more contaminating proteins are depleted by negative chromatography and/or negative adsorption using cation exchanger, hydrophobic gel and/or dye gel. In addition, the invention relates to the fibrinogen which is obtained by the process of the invention and which is notable for improved stability, and to the production and use of pharmaceutical preparations comprising this fibrinogen.

    摘要翻译： 本发明涉及一种用于纯化纤维蛋白原的方法，其包括一个或多个工艺步骤，其中一种或多种污染蛋白质通过阴离子色谱法和/或使用阳离子交换剂，疏水性凝胶和/或染料凝胶的负吸附来消耗。 此外，本发明涉及通过本发明的方法获得并且其显着改进的稳定性的纤维蛋白原以及包含该纤维蛋白原的药物制剂的生产和使用。