ABSTRACT
OBJECTIVE: To develop a heterogeneity analysis method of an antibody-drug conjugate (anti-CD30-vc-MMAE). METHODS: The size and charge heterogeneity of the antibody-drug conjugate (anti CD30-vc-MMAE) was analyzed by SEC-HPLC, CE-SDS, and iCIEF. RESULTS: The main peak purity was (95.69±0.01)% as shown by SEC-HPLC. The total peak purity of the heavy and light chains determined by reduced CE-SDS was (98.38±0.25%)%. At non-reduced CE-SDS level, there were six main peaks, and the total purity of which was (97.82±0.44)%. The acid modification, base modification, and main proportion could be separated effectively by iCIEF, and the peak area percentage of the main peak was (43.52±2.03)%. CONCLUSION: A heterogenecity analysis method of the antibody-drug conjugate (anti-CD30-vc-MMAE) has been preliminarily established and can provide reference for the quality control of this product.