METHOD FOR PREPARING RECOMBINANT HUMAN ERYTHROPOIETIN AND PREPARED ERYTHROPOIETIN, PHARMACEUTICAL COMPOSITION

摘要

FIELD: biotechnology, medicine, pharmacy. SUBSTANCE: recombinant human erythropoietin is prepared by culturing transformed cells CHO producing recombinant erythropoietin in hollow-fiber bioreactors. Method involves repeated inoculation of bioreactors in 7 days, incubation of cellular culture for 16 h up to density value 2.106 cells/ml and onset of fermentation process by continuous perfusion for up to 60 days followed by collection of supernatant enriched with recombinant erythropoietin and centrifugation of cultural medium. Purification of supernatant and fraction is carried out by affinity and ion-exchange chromatography. Recombinant erythropoietin shows 98% of purity degree, biological activity 160 IU/mg and used in pharmaceutical composition for treatment of anemia. Invention provides preparing recombinant human erythropoietin with high specific activity and elimination from blood and highly effective for therapeutic application. Invention is used for preparing recombinant human erythropoietin. EFFECT: improved preparing method, valuable properties of erythropoietin. 4 cl, 9 dwg, 6 ex