Immunogenicity services and capabilities at KCAS Bioanalytical & Biomarker Services

Find out more an electrochemiluminescent bridging immunogenicity assay used to measure anti-drug antibodies in human serum using an acid dissociation step in this poster from KCAS Bioanalytical & Biomarker Services (KS, USA).

INTRODUCTION

Immunogenicity assay guidelines coupled with the importance of evaluation of patients’ immune responses to therapeutic protein products create their own unique hurdles that need to be overcome.

Here we present data outlining an electrochemiluminescent bridging immunogenicity assay used to measure anti-drug antibodies in human serum using an acid dissociation step.

The concern with using acid treatment in an immunogenicity assay is its potential deleterious effect on sensitivity and or drug tolerance. Here we will present assay performance parameters including: cut point determinations, sensitivity, drug tolerance, and selectivity demonstrating an assay that met guidance criteria and was useful to the client.

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