Development of a reporter gene-based assay for the bioactivity determination of rhLH pharmaceutical products

被引：0
作者：
Tang, Defang [1 ]
Song, Xiufang [1 ]
Du, Yanjiao [1 ]
Wang, Jiaxin [1 ]
Lei, Yuqing [1 ]
Chen, Bin [1 ]
机构：
[1] Chengdu Jingze Pharmaceut Co Ltd, 1166 Shuangyan Rd, Chengdu 611137, Peoples R China
来源：
ANALYTICAL BIOCHEMISTRY | 2024年 / 686卷
关键词：
Recombinant human luteinizing hormone; Luciferase reporter gene-based assay; Bioactivity; Method validation; HUMAN LUTEINIZING-HORMONE; ASSISTED REPRODUCTION; LH; STIMULATION;
D O I：
10.1016/j.ab.2023.115413
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
To establish an in vitro biological activity detection method for luteinizing hormone (LH), the hLHCGR-CREBHEK293 cell line was constructed to stably express human luteinizing hormone/chorionic gonadotropin receptor (hLHCGR). After optimization, the rhLH starting working concentration was 800 mIU/mL with 4-fold serial dilutions, 10 concentrations and an incubation time of 5 h. The method was confirmed to be highly specific, with good accuracy, precision and linearity, meeting the needs of process research and release testing, and can be used as a routine detection method for LH biological activity. With the increasing demand for research and development of rhLH biologically similar drugs, establishing a stable and simple activity assay method to evaluate the biological activity of rhLH can provide technical support for quality control of rhLH products and powerful tools for comparability research of similar products.
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页数：8
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