Validation of reduced CE-SDS method for monoclonal antibody drugs
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.
monoclonal antibodyreduced capillary electrophoresisnon-glycosylated heavy chainmethod validationspeci-ficationspecification review
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