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Profiling Anti-Neu5Gc IgG in Human Sera with a Sialoglycan Microarray Assay
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Generic immune complex assay for detection of murine anti-drug-antibodies in complex with human IgG

Lykke Boysen1, Anne M E Sprinkel2, Brian Lauritzen2

  • 1Global Discovery & Development Sciences, Novo Nordisk A/S, Måløv, Denmark; Faculty of Health & Medical Sciences, University of Copenhagen, Frederiksberg C, Denmark.

Biologicals : Journal of the International Association of Biological Standardization
|June 16, 2019
PubMed

Rapid and versatile methods are needed for evaluation of immunogenicity in early safety studies. The present work presents a generic, simple and easy to use sandwich enzyme-linked immunosorbent assay for quasi-quantitative measurement of circulating immune complexes (CICs) formed by anti-drug antibodies (ADAs) in complex with human IgG in mouse plasma. The assay is suitable for evaluating the presence of in vivo formed CICs in mice exposed to human IgG antibodies independent of target and IgG subtype. The assay is established using commercially available antibodies, and calibrated using CIC mimics based on bis(sulfosuccinimidyl)suberate conjugated human and mouse IgG. The development and qualification process of the generic methodology is described and include acceptance criteria, stability, sensitivity, drug tolerance, spike recovery, precision and cut point determination. In order to demonstrate assay performance, its use is exemplified by quantifying CICs in mice administered with a fully human anti-TNF-α IgG1 antibody (adalimumab) or a humanized anti-trinitrophenol (TNP) IgG4 antibody. Results show a well-qualified reproducible assay set-up with adequate sensitivity, easy discrimination between positive and negatives and quasi-quantitative measurement of ADA-human IgG CICs in mice administered with each of two different human/humanized IgG antibodies.

Keywords:
Anti-drug antibody (ADA)Circulating immune complex (CIC)Generic immunoassayImmunogenicity

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