山西医科大学学报2024，Vol.55Issue(7)：916-921,6.DOI:10.13753/j.issn.1007-6611.2024.07.014
单抗药物还原毛细管电泳法方法学验证研究
Validation of reduced CE-SDS method for monoclonal antibody drugs
摘要
Abstract
Objective To perform method validation of reduced capillary electrophoresis-sodium dodecyl sulfate(rCE-SDS)for purity analysis of monoclonal antibodies,and provide a reference for the methodological validation of corresponding quality control methods in the industry.Methods The method of general chapter＜3127＞in Pharmacopoeia of the People's Republic of China(2020 edition)was used to analyze samples,and the specificity,the linearity,the accuracy,the precision,the range,the limit of quantitation and the robustness of the method were validated.Results The specificity of the method was good.The linear fitting results was good(R2＞0.99).The main peak accuracy of each analytical sample was 98％-102％,and the accuracy of total impurities and non-glycosylated heavy chain(NGHC)was 70％-130％.Repeatability and intermediate precision of the assay were both less than 15％.The range of the main peak,total impurities,NGHC was ≥92.4％,0.36％-7.6％,0.12％-3.8％,respectively.The limit of quantification of total impurities and NGHC was 0.36％and 0.12％,respectively.Conclusion All method validation parameters meet the predetermined acceptable criteria,and this study can provide a reference for the scientific and rational design of validation of the corresponding assays.关键词
单抗药物/还原毛细管电泳法/非糖基化重链/方法学验证/质量标准/质量标准复核Key words
monoclonal antibody/reduced capillary electrophoresis/non-glycosylated heavy chain/method validation/speci-fication/specification review分类
医药卫生引用本文复制引用
徐刚领,杜加亮,付志浩,倪永波,于传飞,王兰..单抗药物还原毛细管电泳法方法学验证研究[J].山西医科大学学报,2024,55(7):916-921,6.基金项目
国家重点研发计划蛋白类生物制品主成分及其相关成分精准定量检测技术研究(2021YFF0600804) （2021YFF0600804）
