Establishment of quality control method for anti-interleukin-5 receptor monoclonal antibody
10.13200/j.cnki.cjb.004611
- VernacularTitle:抗白细胞介素-5受体单克隆抗体药物质量控制方法的建立
- Author:
Yalan YANG
1
Author Information
1. Division of Monoclonal Antibody Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Beijing 102629, China
- Publication Type:Journal Article
- Keywords:
Type 2 inflammation;
Interleukin-5 receptor(IL-5R);
Monoclonal antibody;
Critical quality attribute(CQA);
Quality control
- From:
Chinese Journal of Biologicals
2025;38(12):1432-1437
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a drug quality control method for anti-interleukin-5 receptor(IL-5R) monoclonal antibody, in order to provide reference for the quality control of anti-IL-5R monoclonal antibody and other monoclonal antibodies targeting cytokine receptors.Methods The monoclonal antibody was determined for the peptide mapping by reversed-phase ultra-performance liquid chromatography(RP-UPLC), for the charge variants by imaged capillary isoelectric focusing(iCIEF), for the molecular size variants by reduced/non-reduced capillary electrophoresis sodium dodecyl sulfate(CESDS) and size exclusion chromatography(SEC), for the antibody-dependent cell-mediated cytotoxicity(ADCC) activity by reporter gene assay, and for the N-glycan profile by 2-aminobenzamide(2-AB) labeling method.Results The peptide mapping of the anti-IL-5R monoclonal antibody exhibited visual similarity to the reference standard. The iCIEF main peak content was(66. 94 ± 1. 52)%. The reduced CE-SDS heavy chain plus light chain content reached(96. 39 ± 0. 11)%, while the non-reduced main peak content was(96. 98 ± 0. 13)%. The SEC monomer content was(99. 62 ± 0. 06)%. The ADCC biological activity showed a relative potency of(90. 33 ± 15. 42)%. For the N-linked glycan profile, the G1/G0 ratio was(0. 14 ± 0. 00)%, and the high-mannose content was(1. 37 ± 0. 05)%.Conclusion A comprehensive quality control methodology was established for the anti-IL-5R monoclonal antibody, encompassing identity verification, purity analysis, biological activity, and N-linked glycosylation profiling, which provides reference for the development and quality control of therapeutic antibodies against this target and other cytokine receptors.
