Biological characterization of recombinant human erythropoietin.

Highly purified, recombinant, human erythropoietin (rh EPO) has been compared to natural urinary derived erythropoietin (nEPO). Both EPO preparations have been characterized biologically: The proliferation of murine spleen cells in vitro after pretreatment with phenylhydrazine and the 59Fe incorporation into the heme of polycythemic mice have been determined. Further, the effect of rh EPO on the erythropoiesis of normal mice was studied. Depending on the applied rh EPO dosage an increase in hematocrit was observed. Treatment with rh EPO in rats with anemia due to subtotal nephrectomy also showed a dose-dependent rise of hematocrit and hemoglobin, and therefore a reversal of the anemic status. The comparison of rh EPO and natural EPO showed full biological activity of the recombinant protein and its equivalence to the natural hormone.