Abstract Objective: To study and establish a quality control method for some critical quality attributes of the domestic anti-HER2 monoclonal antibodies. Methods: Based on the product characteristics and effects of trastuzumab, the risk assessment of quality attributes was carried out. And some critical quality attributes of 7 batches of the domestic anti-HER2 monoclonal antibody were detected using 7 batches of reference trastuzumabs as the control. The charge heterogeneity was analyzed by ion exchange-high performance liquid chromatography (IEC-HPLC). Biological activity was determined by BT474 cell proliferation inhibition assay. Bio-Layer Interferometry (BLI) was used to measure antigen-antibody affinity, monoclonal antibody affinity with FcRn, and Surface Plasmon Resonance (SPR) was used to measure the affinity of monoclonal antibody with FcγRIIIa. Thermal stability was evaluated by Differential Scanning Calorimetry (DSC). Results: The mean±3SD values of IEC main peak areas percent and EC50 of 7 batches of original trastuzumabs were(73.87±2.21)% and (0.20±0.06)μg·mL-1, respectively. The results of the domestic anti-HER2 monoclonal antibodies were (73.54±3.24)%, (0.20±0.05)μg·mL-1, respectively. The KD values of antigen-antibody affinity, antibody-FcγRIIIa affinity and antibody-FcRn affinity were 1×10-10, 1×10-6, 1×10-7, respectively. The results of 7 batches of the domestic anti-HER2 monoclonal antibodies were 1×10-10, 1×10-6, 1×10-7, respectively. The thermal stability mappings of the domestic anti-HER2 monoclonal antibodies were consistent with those of the original trastuzumabs. Conclusion: A method for quality study of anti-HER2 monoclonal antibody is developed,which provides a reference for quality control of this class domestic monoclonal antibody. |