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Development and Validation of a Simoa Assay for Determination of Recombinant Batroxobin in Human Serum

Curr Med Sci. 2021-06; 
Bian-Zhen Wang, Meng-Jia Wang, Min-Rui Wang, Lun Ou, Li-Hou Dong, Kelly Dong, Hai-Feng Song
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Monoclonal Antibody Services … In this study, we developed and validated a sensitive quantitative method for S3101 in human serum, using Simoa … 1. 1.3 Enzyme-linked Immunosorbent Assay Two monoclonal antibodies, 277G4 and 207D4, were customised by GenScript Biotech Corporation (GenScript … Get A Quote

摘要

Recombinant batroxobin (S3101) is a thrombin-like serine protease that binds to fibrinogen or is taken up by the reticuloendothelial system. A literature survey showed no adequate method that could determine sufficient concentrations to evaluate pharmacokinetic parameters for phase I clinical studies. Therefore, a sensitive method is urgently needed to support the clinical pharmacokinetic evaluation of S3101. In this study, a sensitive bioanalytical method was developed and validated, using a Quanterix single molecular array (Simoa) assay. Moreover, to thoroughly assess the platform, enzyme-linked immunosorbent assay and electrochemiluminescence assay were also developed, and their performance was compared with... More

关键词

electrochemiluminescence assay, enzyme-linked immunosorbent assay, ligand-binding assay, quanterix single molecular array, recombinant batroxobin