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This study summarizes the theoretical background of the protein concentration determination process using UVabsorbance and proposes the standard calculation formular. We analyzed the protein concentration determination processof recombinant DNA-derived biologics that is inspected by the Ministry of Food and Drug Safety for the last three years(2017-2019) and we found some errors in calculation formular. In addition, we analyzed parameters and acceptance criteriaof system suitability test (SST), and we proposed the direction for setting the SST. If the results of this study are widelyunderstood and utilized by product manufacturers and research developers, the calculation of protein concentration usingUV absorbance for each product would be simplified and standardized, and contribute to efficient communication betweenproduct manufacturers and regulatory authority.