Abstract：OBJECTIVE To establish the system suitability standard for N-glycan profile analysis of monoclonal antibodies. METHODS LC-MS was used to characterize the N-linked glycoform of the system suitability standard, and the stability was evaluated. The acceptance criteria of system suitability was set according to the method property and the data from method validation. RESULTS The data of accelerated and long-term stability test indicated that the system suitability standard was stable under storage condition. The N-glycoform of this standard was representative, which covered the main glycoform of monoclonal antibodies. The acceptance criteria of system suitability set for the three analytical METHODS were as below: the detected chromatogram should be visually similar to representative chromatogram; the resolution between G1F(1, 6) and G1F(1, 3), and G0F percentage should meet the specific requirements; the RSD of G0F retention time should be ≤4%. CONCLUSION The standard substance for system suitability test and acceptance criteria for three N-glycan profile analytical METHODS are established.
王文波, 武刚, 于传飞, 张峰, 王兰. 单抗N糖分析系统适用性对照品的建立[J]. 中国药学杂志, 2020, 55(4): 317-321.
WANG Wen-bo, WU Gang, YU Chuan-fei, ZHANG Feng, WANG Lan. Establishment of System Suitability Standard for N-glycan Profile Analysis of Monoclonal Antibodies. Chinese Pharmaceutical Journal, 2020, 55(4): 317-321.
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