IN VITRO BIOLOGICAL ACTIVITY ASSESSMENT OF RHEPO PHARMACEUTICAL FORMULATIONS FOR BATCH RELEASE
Asmaa O. Sana-Eldine*, O. Khamiss and Nahla S. Kotb
ABSTRACT
Background: Recombinant human erythropoietin (rhEPO) is the pharmaceutical form of erythropoietin (EPO), used for the treatment of chronic kidney disease and cancer-associated anemia, act as a growth proliferation factor for cells having EPO- receptor on their surfaces such as blood progenitors, non-hematopoietic cells and some types of tumor cells. Methodology: This study is objectively planned for in vitro biological assessment of rhEPO activity as a routine quality control testing, instead of in vivo animal testing. Malignant cell lines such as MCF-7, HepG2, HELA and PC3 were subjected as expermental cells in this study. Growth rate response for rhEPO treatment was estimated by MTT- based bioassay then was confirmed by hemacytometer and microscopical observation. Results: Statistical records reflected that rhEPO at concentration of 0.78 IU/ml to 25 IU/ml causes cell proliferation expontionally at r >0.9. Using single factor ANOVA (T-test), there is a significant cell proliferation at p <0.005 comparing with non-treated cells. Conclusion: Cell proliferation corresponding to rhEPO can be used as a new approach for quality control testing of rhEPO pharmaceutical products.
Keywords: hemacytometer and microscopical.
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