Publications

Recommendations for Preparation, Design, and Editing of Calibration Curves

The accuracy of reported sample results is contingent upon the quality of the assay calibration curve, and as such, calibration curves are critical components of…

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Meat allergy associated with galactosyl-α-(1,3)-galactose (α-Gal)-Closing diagnostic gaps by anti-α-Gal IgE immune profiling

Abstract Glycoproteins and glycolipids of some mammalian species contain the disaccharide galactosyl-α-(1,3)-galactose (α-Gal). It is known that α-Gal is immunogenic in humans and causes glycan-specific…

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Managing unwanted immunogenicity of therapeutic proteins

Deehan M, Garcês S, Kramer D, Baker M, Rat D, Roettger Y, Kromminga A. Managing unwanted immunogenicity of therapeutic proteins. Autoimmunity Rev. 2015;14,569-574. Abstract All…

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2016 White Paper, Recent Issues in Bioanalysis Part 3 – LBA, Biomarkers, and Immunogenicity

2016 White Paper on recent issues in bioanalysis focus on biomarker assay validation BAV Part 3 – LBA, biomarkers and immunogenicity

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Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study

Abstract A panel of 9 fully human monoclonal antibodies against human erythropoietin (EPO) with defined characteristics (non-neutralizing, neutralizing, various isotypes, affinities) representative of those evident…

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Analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study

Serum pharmacokinetics and cerebrospinal fluid concentration analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study

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B cell epitopes on infliximab identified by oligopeptide microarray with unprocessed patient sera

Autoimmune diseases like rheumatoid arthritis and inflammatory bowel disease are treated with TNF-alpha-blocking antibodies such as infliximab and adalimumab. A common side effect of therapeutic…

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The quintessence of immunogenicity reporting for biotherapeutics

Shankar G, Arkin S, Devanarayan V, Kromminga A, Quarmby V, Richards S, Subramanyam M, Swanson S. The quintessence of immunogenicity reporting for biotherapeutics. Nature Biotech.…

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Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral MSRV-Env protein

Curtin F, Perron H, Kromminga A, Porchet H, Lang AB. Preclinical and early clinical development of GNbAC1, a humanized IgG4 monoclonal antibody targeting endogenous retroviral…

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Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments

Published by The AAPS Journal Abstract For biosimilar drug development, it is critical to demonstrate similar physiochemical characteristics, efficacy, and safety of the biosimilar product…

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