Quality control of human chorionic gonadotrophin subunit dissociation
10.16438/j.0513-4870.2016-0746
- VernacularTitle:毛细管电泳用于测定人绒促性素的解离亚基及其质量控制
- Author:
Qin-pei DENG
1
;
Ran AN
1
;
Tong-ze XU
1
;
Li-xiu HE
1
;
Meng-mei SUN
1
;
Jia-ming YANG
1
;
Yu-cai PENG
1
Author Information
1. Livzon Mabpharm Inc., Zhuhai 519045, China
- Publication Type:ORIGINAL ARTICLES
- Keywords:
human chorionic gonadotrophin;
CE-SDS;
SDS-PAGE;
subunit dissociation;
quality control
- From:
Acta Pharmaceutica Sinica
2017;52(3):430-435
- CountryChina
- Language:Chinese
-
Abstract:
Human chorionic gonadotrophin (hCG), a glycohormone widely used in treatment of infertility, is a heterodimer composed of an alpha-and a beta-subunit. The heterodimer could be dissociated during production and storage with an impact on its bioactivity. A CE-SDS method for quantitative analysis of hCG subunit dissociation was established in this study by optimization of a variety of method conditions including sample preparation buffer compositions, incubation temperature, separation voltage, and capillary temperature. This method was validated for good sensitivity, linearity, precision, and accuracy for both α-and β-subunit. CE-SDS also showed much better precision and accuracy than SDS-PAGE. The method was successfully used in both recombinant hCG (r-hCG) produced by cell culture and hCG (u-hCG) derived from urine. The CE-SDS method was used in the study of hCG development and stability. Therefore, it is an useful tool for the quality control of hCG.
