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    Rights statement: This is the author’s version of a work that was accepted for publication in Journal of Pharmaceutical and Biomedical Analysis. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Journal of Pharmaceutical and Biomedical Analysis, 128, 2016 DOI: 10.1016/j.jpba.2016.05.031

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A false sense of security?: can tiered approach be trusted to accurately classify immunogenicity samples?

Research output: Contribution to journalJournal article

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<mark>Journal publication date</mark>5/09/2016
<mark>Journal</mark>Journal of Pharmaceutical and Biomedical Analysis
Volume128
Number of pages8
Pages (from-to)166-173
Publication statusPublished
Early online date27/05/16
Original languageEnglish

Abstract

Detecting and characterizing of anti-drug antibodies (ADA) against a protein therapeutic are crucially important to monitor the unwanted immune response. Usually a multi-tiered approach that initially rapidly screens for positive samples that are subsequently confirmed in a separate assay is employed for testing of patient samples for ADA activity. In this manuscript we evaluate the ability of different methods used to classify subject with screening and competition based confirmatory assays. We find that for the overall performance of the multi-stage process the method used for confirmation is most important where a t-test is best when differences are moderate to large. Moreover we find that, when differences between positive and negative samples are not sufficiently large, using a competition based confirmation step does yield poor classification of positive samples.

Bibliographic note

This is the author’s version of a work that was accepted for publication in Journal of Pharmaceutical and Biomedical Analysis. Changes resulting from the publishing process, such as peer review, editing, corrections, structural formatting, and other quality control mechanisms may not be reflected in this document. Changes may have been made to this work since it was submitted for publication. A definitive version was subsequently published in Journal of Pharmaceutical and Biomedical Analysis, 128, 2016 DOI: 10.1016/j.jpba.2016.05.031