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

Jaki, Thomas Friedrich and Allacher, Peter and Horling, Frank (2016) A false sense of security?:can tiered approach be trusted to accurately classify immunogenicity samples? Journal of Pharmaceutical and Biomedical Analysis, 128. pp. 166-173. ISSN 0731-7085

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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.

Item Type:
Journal Article
Journal or Publication Title:
Journal of Pharmaceutical and Biomedical Analysis
Additional Information:
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
Uncontrolled Keywords:
/dk/atira/pure/subjectarea/asjc/1300/1308
Subjects:
ID Code:
79812
Deposited By:
Deposited On:
03 Jun 2016 08:56
Refereed?:
Yes
Published?:
Published
Last Modified:
07 Apr 2020 03:55