Erythropoietin is a glycoprotein hormone that stimulates production of red blood cells in the body and is significant for chronic kidney patients associated anemia. It is thus important to assess the efficacy and safety of this product before its entry into the market. In the present study Quality Control testing of recombinant human Erythropoietin (rhEPO) was carried out as per the procedures and specifications laid down in Indian Pharmacopoeia (IP, 2018). In-vivo bioassay for potency estimation was done for Erythropoietin Injection by measurement of stimulation of reticulocyte production in normocythaemic mice using reticulocyte counting by flow cytometry. The biological activity of 54 different batches of rhEPO was compared with that of Erythropoietin Reference Standard and was expressed in International Units (IU). The results of potency estimation obtained at our laboratory at National Institute of Biologicals (NIB) were also compared with manufacturers result as per their Certificate of Analysis (COA) for 20 out of 54 batches of rhEPO and were found to be within the limits prescribed and difference was not statistically significant when plotted on QC Chart. Thus, the present study demonstrates that the potency estimation of rhEPO by used method as per IP 2018 at NIB is well standardized and validated method. Therefore, it is essential that a robust, well-characterized methodology be applied to ensure batch-to-batch consistency in biopotency among the different manufacturers in order to guarantee high quality and therapeutic efficacious Erythropoietin in Indian market.
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