PREPARATION OF PHARMACEUTICAL PREPARATION CONTAINING HEMO-COAGULATION IX FACTOR

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.