Advisory Board Member

Dr Arno Kromminga

Arno is an expert in immunogenicity and regulated bioanalysis. He has developed numerous assays in regulated bioanalysis in his career since mid of the 1990s. He consults on strategies to develop and validate assays for successful drug approval processes. He applies his skills to a broad range of therapeutic areas including Advanced Therapeutic Medicinal Products (ATMP), complex multi-domain constructs (MDC) and others.

Arno is a member of Immunogenicity Integrated, this is a platform created by three members of the NDA Advisory Board, who combine extensive multi-disciplinary experience of assessing immunogenicity for different biotherapeutic modalities, including ATMPs. Deeper understanding of intrinsic and extrinsic factors that may influence immunogenicity enables de-risking of the product development process in a manner that is fully aligned with regulatory expectations. NDA group and Immunogenicity Integrated work in close partnership to provide documentation, including risk assessment for Clinical Trial Applications and Scientific Advice meetings, and the Integrated Summary of Immunogenicity for global registration dossiers.

Key Areas Of Expertise
  • Support of client projects in the field of biologics and ATMP project, for the purpose of preparation of development milestones, and Marketing Authorisation (MA) Applications
  • Translational, mechanistic immunology and early development strategies in support of therapeutics (including Biosimilars, ATMP, MDC etc.) and vaccine projects
  • Quantitative and qualitative risk assessment in support of clinical and non-clinical projects with an emphasis on immune-mediates effects (efficacy and safety assessment); this included risk-based approaches to mitigate immunogenicity
  • Integrated Summary of Immunogenicity (ISI)
  • Bio-analytical strategies, assay strategy and assay design in support of clinical biomarker-based approaches
  • Audits and due diligences
  • Professional presentation skills and extensive teaching experience as Adjunct professor in Immunology at University of Kiel
Before Joining The NDA Advisory Board

Arno is the founder of the specialized bioanalytical laboratory IPM Biotech which is now BioAgilytix Europe. Before he served as the Head of Immunology at a Medical Laboratory of  Sonic Healthcare. Arno is the co-founder and board member of the European Immunogenicity Platform (EIP), member of the American Association of Pharmaceutical Scientists (AAPS)  and other organizations. He is author of multiple publications and book chapters and is an invited speaker at international conferences. He has a PhD in Biochemistry and is a certified Immunologist. He is Adjunct Professor in Immunology at the University of Kiel, Germany.

Recent Publications

Gorovits B, Peng K, Kromminga A. Current Considerations on Characterization of Immune Response to Multi-Domain Biotherapeutics. BioDrugs. 2020;34(1):39-54

Homann A, Röckendorf N, Kromminga A, Frey A, Platts-Mills TA, Jappe U. Glycan and Peptide IgE Epitopes of the TNF-alpha Blockers Infliximab and Adalimumab - Precision Diagnostics by Cross-Reactivity Immune Profiling of Patient Sera. Theranostics. 2017;17;7(19):4699-4709

Wadhwa M, Mytych DT, Bird C, Barger T, Dougall T, Han H, Rigsby P, Kromminga A, Thorpe R; Participants of the Study. Establishment of the first WHO Erythropoietin antibody reference panel: Report of an international collaborative study. J Immunol Methods. 2016;435:32-42

Shankar G, Arkin S, Devanarayan V, Kromminga A, Quarmby V, Richards S, Subramanyam M, Swanson S. The quintessence of immunogenicity reporting for biotherapeutics. Nat Biotechnol. 2015;33(4):334-6

Dr Arno Kromminga



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