A novel reporter gene assay for Recombinant Human Erythropoietin (rHuEPO) pharmaceutical products

- A UT-7/epo cell line stably transfected with luciferase gene under the control of SIE and GAS promoter was constructed.
- A reporter gene assay for potency determination of rHuEPO was established and the procedure was optimized.
- The reporter gene assay was validated for its precision, accuracy, specificity and robustness.
- The consistency of reporter gene assay with reticulocyte assay was evaluated by Bland-Altman analysis.