Determination of biological activity of teduglutide by a homogeneous time-resolved fluorescence method
10.16438/j.0513-4870.2024-0513
- VernacularTitle:均相时间分辨荧光技术测定替度格鲁肽生物学活性
- Author:
Xiao-ming ZHANG
1
;
Ran MA
2
;
Li-jing LÜ
3
;
Lü-yin WANG
1
;
Ping LÜ
1
;
Cheng-gang LIANG
1
;
Jing LI
1
Author Information
1. National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, Beijing
2. Beijing Institute of Petrochemical Technology, Beijing
3. Taian Institute for Food and Drug Control, Taian Fiber Inspection Institute, Taian
- Publication Type:Research Article
- Keywords:
teduglutide;
bioactivity;
quality control;
method validation;
homogeneous time-resolved fluorescence
- From:
Acta Pharmaceutica Sinica
2025;60(1):211-217
- CountryChina
- Language:Chinese
-
Abstract:
In this study, we constructed a GLP-2R-HEK293 cell line and established a method for the determination of the in vitro biological activity of teduglutide based on HTRF, after optimizing experimental conditions and methodological verification. We also carried out relative potency detection of teduglutide pharmaceutical products using this method. The result showed that there was a quantitative-efficient relationship between the teduglutide activity and cAMP contents in GLP-2R-HEK293 cells, which conformed to four-parameter model. Method verification results of five concentrations of teduglutide (64%, 80%, 100%, 125% and 156%) met the requirements of the General Rules of Chinese Pharmacopoeia, 2020 edition, Volume IV (9401). We then analyzed the relative potency of three batches of teduglutide drug substances and three batches of drug products. The linearity, regression and parallelism of the obtained curves all fit the system suitability requirements. The relative potency of six batches of teduglutide was from 83% to 105%. In summary, the biological activity detection method established in this study was accurate, precise, simple and time-saving, which can be used for quality control of teduglutide pharmaceutical products.
