Methodological validation study of nrCE-SDS for monoclonal antibodies
Objective To perform methodological validation of non-reduced capillary electrophoresis-sodium dodecyl sulfate (nrCE-SDS) for monoclonal antibodies, providing a reference for the methodological validation of corresponding quality control methods in the industry. Methods Samples were analyzed accordi...
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| Format: | Article |
| Language: | zho |
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Lanzhou University Press
2024-12-01
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| Series: | 生物医学转化 |
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| Online Access: | http://swyxzh.ijournals.cn/swyxzh/article/html/20240410 |
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| author | Xu Gangling Ni Yongbo Wu Gang Fu Zhihao Yu Chuanfei Wang Lan |
| author_facet | Xu Gangling Ni Yongbo Wu Gang Fu Zhihao Yu Chuanfei Wang Lan |
| author_sort | Xu Gangling |
| collection | DOAJ |
| description | Objective To perform methodological validation of non-reduced capillary electrophoresis-sodium dodecyl sulfate (nrCE-SDS) for monoclonal antibodies, providing a reference for the methodological validation of corresponding quality control methods in the industry. Methods Samples were analyzed according to the general chapter ＜3127＞ determination method for monoclonal antibody molecular size variants in the Pharmacopoeia of the People's Republic of China (2020 edition). Two laboratory technicians performed experiments over three days, using the same detection method daily to analyze the test samples, alongside comprehensive methodological validation. Results The method demonstrated good specificity, with the accuracy of the main peaks of all analytical samples reaching 98% to 102%, and the accuracy of total fragments and specific impurities reaching 70% to 130%. The relative standard deviation (RSD) for repeatability and intermediate precision was ≤15%. The ranges for the main peak, total fragment, and specific impurity were ≥89.9%, 0.66% to 10.10%, and 0.36% to 4.80%, respectively.The limit of quantification of the method was 0.33%. Conclusion Full validation demonstrates good accuracy, precision, linearity, range, limit of quantification, and specificity of the method, providing a reference for the scientific and rational design of corresponding methodological validations. |
| format | Article |
| id | doaj-art-71aabc7be845429ca292bd0b13dd44c4 |
| institution | OA Journals |
| issn | 2096-8965 |
| language | zho |
| publishDate | 2024-12-01 |
| publisher | Lanzhou University Press |
| record_format | Article |
| series | 生物医学转化 |
| spelling | doaj-art-71aabc7be845429ca292bd0b13dd44c42025-08-20T02:35:44ZzhoLanzhou University Press生物医学转化2096-89652024-12-01548286,9510.12287/j.issn.2096-8965.20240410Methodological validation study of nrCE-SDS for monoclonal antibodiesXu Gangling0Ni Yongbo1Wu Gang2Fu Zhihao3Yu Chuanfei4Wang Lan5Division of Monoclonal Antibodies, National Institutes for Food and Drug Control, State Key Laboratory of Drug RegulatoryScience, National Health Commission Key Laboratory of Research on Quality and Standardization of Biotech Products,National Medical Products Adminstration Key Laboratoryfor Quality Research and Evaluation of Biological Products, Beijing 102629 , ChinaDivision of Monoclonal Antibodies, National Institutes for Food and Drug Control, State Key Laboratory of Drug RegulatoryScience, National Health Commission Key Laboratory of Research on Quality and Standardization of Biotech Products,National Medical Products Adminstration Key Laboratoryfor Quality Research and Evaluation of Biological Products, Beijing 102629 , ChinaDivision of Monoclonal Antibodies, National Institutes for Food and Drug Control, State Key Laboratory of Drug RegulatoryScience, National Health Commission Key Laboratory of Research on Quality and Standardization of Biotech Products,National Medical Products Adminstration Key Laboratoryfor Quality Research and Evaluation of Biological Products, Beijing 102629 , ChinaDivision of Monoclonal Antibodies, National Institutes for Food and Drug Control, State Key Laboratory of Drug RegulatoryScience, National Health Commission Key Laboratory of Research on Quality and Standardization of Biotech Products,National Medical Products Adminstration Key Laboratoryfor Quality Research and Evaluation of Biological Products, Beijing 102629 , ChinaDivision of Monoclonal Antibodies, National Institutes for Food and Drug Control, State Key Laboratory of Drug RegulatoryScience, National Health Commission Key Laboratory of Research on Quality and Standardization of Biotech Products,National Medical Products Adminstration Key Laboratoryfor Quality Research and Evaluation of Biological Products, Beijing 102629 , ChinaDivision of Monoclonal Antibodies, National Institutes for Food and Drug Control, State Key Laboratory of Drug RegulatoryScience, National Health Commission Key Laboratory of Research on Quality and Standardization of Biotech Products,National Medical Products Adminstration Key Laboratoryfor Quality Research and Evaluation of Biological Products, Beijing 102629 , ChinaObjective To perform methodological validation of non-reduced capillary electrophoresis-sodium dodecyl sulfate (nrCE-SDS) for monoclonal antibodies, providing a reference for the methodological validation of corresponding quality control methods in the industry. Methods Samples were analyzed according to the general chapter ＜3127＞ determination method for monoclonal antibody molecular size variants in the Pharmacopoeia of the People's Republic of China (2020 edition). Two laboratory technicians performed experiments over three days, using the same detection method daily to analyze the test samples, alongside comprehensive methodological validation. Results The method demonstrated good specificity, with the accuracy of the main peaks of all analytical samples reaching 98% to 102%, and the accuracy of total fragments and specific impurities reaching 70% to 130%. The relative standard deviation (RSD) for repeatability and intermediate precision was ≤15%. The ranges for the main peak, total fragment, and specific impurity were ≥89.9%, 0.66% to 10.10%, and 0.36% to 4.80%, respectively.The limit of quantification of the method was 0.33%. Conclusion Full validation demonstrates good accuracy, precision, linearity, range, limit of quantification, and specificity of the method, providing a reference for the scientific and rational design of corresponding methodological validations.http://swyxzh.ijournals.cn/swyxzh/article/html/20240410monoclonal antibodypuritynon-reduced capillary electrophoresismethodological validationquality control |
| spellingShingle | Xu Gangling Ni Yongbo Wu Gang Fu Zhihao Yu Chuanfei Wang Lan Methodological validation study of nrCE-SDS for monoclonal antibodies 生物医学转化 monoclonal antibody purity non-reduced capillary electrophoresis methodological validation quality control |
| title | Methodological validation study of nrCE-SDS for monoclonal antibodies |
| title_full | Methodological validation study of nrCE-SDS for monoclonal antibodies |
| title_fullStr | Methodological validation study of nrCE-SDS for monoclonal antibodies |
| title_full_unstemmed | Methodological validation study of nrCE-SDS for monoclonal antibodies |
| title_short | Methodological validation study of nrCE-SDS for monoclonal antibodies |
| title_sort | methodological validation study of nrce sds for monoclonal antibodies |
| topic | monoclonal antibody purity non-reduced capillary electrophoresis methodological validation quality control |
| url | http://swyxzh.ijournals.cn/swyxzh/article/html/20240410 |
| work_keys_str_mv | AT xugangling methodologicalvalidationstudyofnrcesdsformonoclonalantibodies AT niyongbo methodologicalvalidationstudyofnrcesdsformonoclonalantibodies AT wugang methodologicalvalidationstudyofnrcesdsformonoclonalantibodies AT fuzhihao methodologicalvalidationstudyofnrcesdsformonoclonalantibodies AT yuchuanfei methodologicalvalidationstudyofnrcesdsformonoclonalantibodies AT wanglan methodologicalvalidationstudyofnrcesdsformonoclonalantibodies |