confirm the presence of antigen in the Active raw material of rEPO

One of the important aspects in the production of recombinant biological products, based on the rules of GMP, is accuracy in product quality control. After production of recombinant erythropoietin medication, it is necessary to confirm the presence of antigen in the Active raw material of the antigens production process and prove that their property is not been lost and is present in the material. Confirming the presence of antigen must be done with one of the most common immunological methods such as dot blot, Western blot or ELISA. Now, the test is done by commercial kits. Because of the difficulties with the kits, including high cost, reduction in the sensitivity of the kit because of the lack of suitable transportation conditions, distance (cold chain) and shopping difficulties, most of these kits are purchased in large quantities and after arrival to the country, they are stored for a long time, and lose their stability and efficiency, so the results are out of range and unreliable. Due to these problems, the identification production of antibodies against the recombinant erythropoietin antigen and doing tests these products reduce costs, provide fast desired antibodies, and increase the sensitivity, high efficiency and reliability of their results.