earticle

영어

The N-glycan profile of a biologics, especially therapeutic antibody is commonly defined as a critical quality attribute (CQA) in bioprocess development. Fc glycosylation is reported to be important in the antibody-dependnet cell-mediated cytotoxicity (ADCC) and for complement-dependent cytotoxicity (CDC) functions through modulating the binding to Fcy receptors and C1q respectively. Removal of core fucose can also increase the ADCC. Therefore the analysis of N-glycan is very important and critical in the function of therapeutic antibodies. Recently, most of the analytical techniques in N-glycan analysis are using PNGase and Fluorescent labeling such as 2-AB. Resultant released glycans are analysed in the HPLC coupled with fluorescent detector and Mass. As the methods take 2~3 day to get the results it cannot be good ones in bioprocess development of therapeutic antibodies that they are requiring rapid analysis. Here, we tested an N-glycan labeling method that could provide rapid and enhanced fluorescence response/Mass sensitivity in the detection of N-glycan. Furthermore, this method has simplicity and high throughput capacity.