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    • 7. 发明授权
    • 분배제로서카프릴산나트륨을사용하는저온알부민분획법
    • KR100418821B1
    • 2004-05-20
    • KR1019950024363
    • 1995-08-08
    • 바이엘 코포레이션
    • 로버트에이.테놀드
    • A61K38/16
    • C07K14/765A61K38/00Y10S530/829Y10S530/83
    • Highly stable plasma-derived therapeutic albumin solutions, having a turbidity level of 5 NTU or less can be made by adding sodium caprylate to Cohn fraction II+III or IV-1 effluent at relatively low temperatures. The sodium caprylate acts as a partitioning agent to separate albumin from unwanted proteins. In preferred embodiments, the albumin source solution temperature is elevated, increased in pH and reacted for approximately six hours under conditions sufficient to disrupt the initial solution colloid, and partition albumin-containing supernatant from a colloidal disperse phase, which retains unwanted globulins and manufacturing debris. Since it tends to be a scavenger molecule, albumin is selectively stabilized by diafiltration against a buffer containing sodium caprylate, thereby assuring a high albumin monomer content and low turbidity level. The amount of sodium caprylate required for selective stabilization is determined by the amount of available binding sites on the albumin molecule.
    • 浊度水平为5NTU或更低的高度稳定的血浆来源的治疗性白蛋白溶液可以通过在相对低的温度下将辛酸钠加入到Cohn级分II + III或IV-1流出物中来制备。 辛酸钠作为分离剂将白蛋白与不需要的蛋白质分开。 在优选的实施方案中,白蛋白源溶液温度升高,pH升高并且在足以破坏初始溶液胶体的条件下反应约6小时,并且从胶体分散相分离含有白蛋白的上清液,其保留不需要的球蛋白和制造碎片 。 由于它倾向于是清道夫分子,因此通过对含有辛酸钠的缓冲液进行渗滤来选择性地稳定白蛋白,从而确保高白蛋白单体含量和低浊度水平。 选择性稳定化所需的辛酸钠的量由白蛋白分子上可用的结合位点的量决定。
    • 8. 发明授权
    • 사람활성화단백질C제제및이의제조방법
    • 사람활성화단백질Ç제제및이의제조방법
    • KR100383063B1
    • 2003-07-07
    • KR1019960702106
    • 1994-10-27
    • 잇빤 자이단호진 가가쿠오요비겟세이료호겐쿠쇼테이진 가부시키가이샤
    • 오가타요이치노우치토시노부나카히라신지
    • C12N9/64
    • C12N9/6464C12Y304/21069Y10S530/83Y10S530/856
    • A human Activated Protein C preparation with a high specific activity being substantially free from thrombin or an equivalent protease and/or Protein C not being subjected to activation and a process for preparing the same are provided. A human Activated Protein C preparation which shows specific activity of 3500 U/mg or more, the unit of specific activity being defined as an amount of APC which prolongs twice an activated thromboplastin time (APTT) of normal human plasma, and is substantially free from thrombin or an equivalent protease and/or Protein C not being subjected to activation. Said preparation is prepared by a process for purification of human Activated Protein C which comprises, after activation of Protein C with thrombin or an equivalent protease, contacting a solution containing human Activated Protein C with a cation exchanger to allow for adsorption of thrombin and Activated Protein C to the exchanger, and then eluting human Activated Protein C alone.
    • 提供具有高比活性的人活化蛋白C制剂基本不含凝血酶或未经活化的等同蛋白酶和/或蛋白质C及其制备方法。 表现出3500U / mg或更高的比活性的人活化蛋白C制剂,比活性单位被定义为延长正常人血浆活化凝血活酶时间(APTT)两倍的APC量,并且基本上不含 凝血酶或相当的蛋白酶和/或蛋白质C未受激活。 所述制剂通过纯化人活化蛋白C的方法制备,所述方法包括在用凝血酶或等效蛋白酶活化蛋白C后,使含有人活化蛋白C的溶液与阳离子交换剂接触以允许吸附凝血酶和活化蛋白 C加入交换器中,然后单独洗脱人活化蛋白C.