Determination of biological activity of Insulin Icodec using homogeneous time-resolved fluorescence method
WANG Lü-yin
GAO Jing
LI He-yang
ZHANG Xiao-ming
LÜ Ping
LI Jing
LIANG Cheng-gang
Abstract：Objective:To establish a novel bioassay to determine the bioactivity of Insulin Icodec based on homogeneous time-resolved fluorescence immunoassay technique.Methods:Utilizing CHO-INSR B1284 cells as the target cells,the bioassay was established by optimizing the drug dose-response range of Insulin Icodec,stimulation duration,and seeding density of the target cells.Comprehensive methodological validation was performed in accordance with the General Rules of Chinese Pharmacopoeia,2020 edition,Volume IV(9401).We also carried out relative potency detection of Insulin Icodec pharmaceutical products and other insulin analogues drugs.Results:The results showed that Insulin Icodec exhibits a dose-response relationship with the following four-parameter equation:y=(A-D)/[1+(x/C)B]+D.The method showed good specificity.The geometric mean values,relative biases,and geometric coefficients of variation(GCV,%)of five concentrations of Insulin Icodec(50%,80%,100%,125%and 200%)met the requirements of the General Rules of Chinese Pharmacopoeia,2020 edition,Volume IV(9401).We also analyzed the relative potency of three batches of Insulin Icodec drug substances and three batches of drug products.The linearity,regression and parallelism of the dose-response curves all fit the reliability requirements.Conclusion:The biological activity detection method established in this study was simple,time-saving,accurate and precise,which can be further used for the evaluation of the biological activity of Insulin Icodec products.
Keywords：Insulin Icodecquality controlbioactivityhomogeneous time-resolved fluorescencemethod validation
Publication Date：2025-06-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 1170-1177 )