PREPARATION OF PHARMACEUTICAL PREPARATION CONTAINING HEMO-COAGULATION IX FACTOR

    公开(公告)号:JPH08259449A

    公开(公告)日:1996-10-08

    申请号:JP4499596

    申请日:1996-03-01

    申请人: IMMUNO AG

    摘要: PROBLEM TO BE SOLVED: To obtain a pharmaceutical preparation containing blood coagulation factor IX and useful for replacement therapy of hemophilia B patients. SOLUTION: One of factor IX derived from aqueous mixture containing at least one plasma zymogen in addition to blood coagulation factor IX is brought into contact with a carrier based on a polymer having hydrophobic group and selectively bound to the blood coagulation factor IX to prepare a coagulation factor IX complex. The complex can contain vitamin K-dependent protein (e.g. protein C) in addition to the factor IX. Then, the factor IX is eluted by using hydrophobic chromatography from the coagulation factor IX complex to afford an eluate containing the factor IX, which is then formulated into a pharmaceutical preparation. The aqueous mixture containing the factor IX having preferably 60-120 ms conductivity is used in order to prepare the complex and the elution is carried out in conductivity condition lower by maximum 20% than conductivity of the aqueous mixture containing the factor IX. The complex can further be used for obtaining monoclonal antibody or polyclonal antibody specific to the factor IX.

    COMPLEX CONTAINING BLOOD COAGULATION FACTOR IX

    公开(公告)号:JPH04295432A

    公开(公告)日:1992-10-20

    申请号:JP1079792

    申请日:1992-01-24

    申请人: IMMUNO AG

    摘要: PURPOSE: To efficiently isolate the blood coagulating factor IX useful for the replacement therapy of hemophilia B from an aqueous mixture containing at least one plasma zymogen in addition to the factor IX. CONSTITUTION: This coagulation factor IX is eluted from a coagulation factor IX complex, and the obtained solution containing the coagulation factor IX is processed into a pharmaceutical preparation. The coagulation factor IX complex comprises a carrier based on a polymer containing hydrophobic groups, to which the factor IX is selectively bound, and the coagulation factor IX originated from an aqueous mixture containing at least one plasma zymogen, preferably a vitamin K-dependent protein selected from protein S, the factor II, the factor VII, especially prothrombin, in addition to the factor IX, preferably the factor IX having the higher activity fine times or larger than those of other vitamin K-dependent proteins contained in the aqueous mixture.

    BLOOD PRODUCT, METHOD FOR ITS PRODUCTION AND METHOD FOR DETERMINING VIRUS INACTIVATING ABILITY IN INACTIVATING TREATMENT

    公开(公告)号:JPH05186358A

    公开(公告)日:1993-07-27

    申请号:JP16094892

    申请日:1992-06-19

    申请人: IMMUNO AG

    摘要: PURPOSE: To provide a blood preparation inactivated in relation to infectious substances, to provide a method for producing the preparation, and to provide a method for determining the virus inactivation capacity of the inactivation treatment. CONSTITUTION: This inactivated blood preparation is obtained (a) by treating a blood preparation in an aqueous solution containing a surfactant in an amount of at least 2%, preferably at least 5%, and subsequently thermally treating the product in a solid state or (b) by thermally treating the blood preparation in a solid state and subsequently treating the product in an aqueous solution containing a surfactant in an amount of at least 2%, preferably at least 5%. The inactivation treatment gives the blood preparation inactivated in relation to infectious substances, and having a whole virus decrease coefficient of at least 40 and a biological activity of at least 50% based on the activity before the inactivation of the infectious substances. The thermal treatment of the blood preparation in the solid and dry state is preferably carried out under a water content condition of 0.05-0.70. The method of determining the virus inactivation capacity of the inactivation treatment comprises repeatedly adding test viruses during the inactivation treatment and totalizing individual decrease coefficients to obtain the total virus decrease coefficient.