Qualification and application of a surface plasmon resonance-based assay for monitoring potential HAHA responses induced after passive administration of a humanized anti Lewis-Y antibody

Journal of Pharmaceutical and Biomedical Analysis
O H J SzolarA Nechansky

Abstract

A sensitive, surface plasmon resonance (SPR)-based assay monitoring potential human-anti-human antibody (HAHA) reactions against the monoclonal antibody (mAb) IGN311 is presented. The latter is a fully humanized Lewis-Y carbohydrate specific mAb that is currently tested in a passive immune therapy approach in a clinical phase I trial. For the SPR experiments a BIACORE 3000 analyzer was used. The ligand IGN311 was covalently coupled to the carboxy-methylated dextran matrix of a CM5 research grade chip (BIACORE). In the course of a fully nested experimental design, a four parameter logistic equation was identified as appropriate calibration model ranging from 0.3 microg/mL (lower limit of quantitation, LLOQ) to 200 microg/mL (upper limit of quantitation, ULOQ) using an anti-idiotypic mAb ('HAHA mimic') as calibrator. The bias ranged from -2.4% to 5.5% and the intermediate precision expressed as 95% CI revealed values from 5.6% to 8.3%. Specificity was evaluated using six human serum matrices from healthy donors spiked with calibrator at the limit of quantitation (LOQ) with >80% of values being recovered with less than 25% relative error. The qualified assay was applied to monitor potentially induced HAHA reactivity in 11 patients...Continue Reading

Citations

Nov 1, 2010·Expert Opinion on Drug Discovery·Andreas Nechansky, Ralf Kircheis
Jun 9, 2007·The International Journal of Biochemistry & Cell Biology·Xuesong YangQiu Yan
Oct 4, 2014·Journal of Pharmaceutical and Biomedical Analysis·C GassnerJ Moelleken
Dec 13, 2007·Journal of Molecular Recognition : JMR·Rebecca L Rich, David G Myszka

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