Ezan, Eric and Bitsch, Francis (2009) Critical comparison of mass spectrometry and immunoassays for the bioanalysis of therapeutic antibodies. BioAnalysis, 1 (8). pp. 1375-1388. ISSN 1757-6180

Abstract

Therapeutic antibody assessment in biofluids requires fit-for-purpose bioanalytical methods. The reference is the immunoassay, the accuracy of which may be compromised by interference by endogenous components. Here we report the inherent analytical problems posed by immunoassays and propose an alternative based on liquid chromatography/mass spectrometry that should be readily applicable to analysis of therapeutic antibodies in biological fluids. We review problems linked to assay sensitivity, the choice of the assay format involving either immunodetection or mass spectrometry, and strategies in the assessment of bound vs. free forms.

Item Type:	Article
Additional Information:	Author can archive post-print (ie final draft post-refereeing); 12 month embargo for institutional or subject based servers
Keywords:	Mass spectrometry; ELISA; interference; immunogenicity; recombinant; drug; antibody
Date Deposited:	13 Oct 2015 13:17
Last Modified:	13 Oct 2015 13:17
URI:	https://oak.novartis.com/id/eprint/1293