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Determination of biological activity of teduglutide by a homogeneous time-resolved fluorescence method
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Xiao-ming ZHANG1, Ran MA2, Li-jing LÜ3, Lü-yin WANG1, Ping LÜ1, Cheng-gang LIANG1, *, Jing LI1, *
Acta Pharmaceutica Sinica | 2025, 60(1) : 211 - 217
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Acta Pharmaceutica Sinica | 2025, 60(1): 211-217
• Original Articles •
Determination of biological activity of teduglutide by a homogeneous time-resolved fluorescence method
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Xiao-ming ZHANG1, Ran MA2, Li-jing LÜ3, Lü-yin WANG1, Ping LÜ1, Cheng-gang LIANG1, *, Jing LI1, *
Affiliations
  • 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 102629, China
  • 2. Beijing Institute of Petrochemical Technology, Beijing 102617, China
  • 3. Taian Institute for Food and Drug Control, Taian Fiber Inspection Institute, Taian 271000, China
Published: 2025-01-12 doi: 10.16438/j.0513-4870.2024-0513
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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.

teduglutide  /  bioactivity  /  quality control  /  method validation  /  homogeneous time-resolved fluorescence
Xiao-ming ZHANG, Ran MA, Li-jing LÜ, Lü-yin WANG, Ping LÜ, Cheng-gang LIANG, Jing LI. Determination of biological activity of teduglutide by a homogeneous time-resolved fluorescence method[J]. Acta Pharmaceutica Sinica, 2025 , 60 (1) : 211 -217 . DOI: 10.16438/j.0513-4870.2024-0513
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Year 2025 volume 60 Issue 1
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Article Info
doi: 10.16438/j.0513-4870.2024-0513
  • Receive Date：2024-05-28
  • Online Date：2025-11-07
  • Published：2025-01-12
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History
  • Received：2024-05-28
  • Revised：2024-10-19
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Affiliations
    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 102629, China
    2. Beijing Institute of Petrochemical Technology, Beijing 102617, China
    3. Taian Institute for Food and Drug Control, Taian Fiber Inspection Institute, Taian 271000, China
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表12种不同金属材料的力学参数
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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