자외선 흡광도를 이용한 유전자재조합의약품 함량 결정과정 분석

Analysis of Protein Content Determination Using UV Absorbance in Recombinant DNA-derived Biologics

This study summarizes the theoretical background of the protein concentration determination process using UV absorbance and proposes the standard calculation formular. We analyzed the protein concentration determination process of 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 criteria of system suitability test (SST), and we proposed the direction for setting the SST. If the results of this study are widely understood and utilized by product manufacturers and research developers, the calculation of protein concentration using UV absorbance for each product would be simplified and standardized, and contribute to efficient communication between product manufacturers and regulatory authority.