METHOD FOR MAKING HUMAN COAGULATION FACTOR IX CONCENTRATE

摘要

FIELD: medicine. ^ SUBSTANCE: invention refers to biotechnology and pharmaceutical industry area and concerns methods for making frozen-dried high-purity blood plasma factor IX preparation. In the present invention supernatant made of plasma after solvent-detergent processing is applied on an anion-exchange column to concentrate factor IX and remove viral inactivation components. Then salt fractionation follows with ammonium sulphate. This reasonably priced and effective stage allows eliminating the majority of prothrombin-complex impurity factors with keeping those components well separated from end protein at the following stage. The last stage involves final purification by metalchelate chromatography. The problem of the invention is to simplify blood plasma factor IX technology enabling for high-active product to be effective in clinical practice. ^ EFFECT: invention aims at simplifying the method for making coagulation factor IX of high specific activity of protein 150-200 ME/mg. ^ 2 cl, 2 ex