Publications
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…
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…
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
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…
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
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…
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.…
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…
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…
Recommendations on incurred sample stability (ISS) by GCC
Abstract The topic of incurred sample stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part…