Heterogenecity analysis of anti-cluster of differentiation 30-vc-MMAE / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 1091-1095, 2016.
Article
in Chinese
| WPRIM
| ID: wpr-859056
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Chinese Pharmaceutical Journal
Year:
2016
Type:
Article
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