Ultimately, all biological drugs are immunogenic. Over the last several years, methods for the detection of drug-induced antibodies have become more sensitive, which means that target sensitivities of 100 ng/mL can be easily reached. But, the question remains to be answered: are antibodies at this low concentration level clinically relevant? In addition, do antibodies against biological drugs that are detectable prior to the initiation of the treatment have any clinical implication? This webinar will discuss why careful and thorough data interpretation is needed, which takes into account the clinical manifestation of clinically relevant biomarkers (including PK).
What will you learn?
- Why careful and thorough data interpretation is needed to understand if antibodies in the low nanogram range are clinically relevant
- How the kinetics and type of antibody responses should be monitored to assess the risk of developing a treatment-emergent immune response
- Why post-approval patient monitoring should be mandatory
Who may this interest?
- Quality Managers
PD Dr Arno Kromminga
SVP & Chief Scientific Officer
BioAgilytix Europe (Hamburg, Germany)
Dr Kromminga is an esteemed senior expert for the assessment of immunogenicity of biologicals. He and his team have developed and validated numerous assays in immunogenicity and drug monitoring for preclinical and clinical studies. One of his major interests includes the interpretation of results to obtain clinically meaningful data. He studied Biochemistry and is a certified Clinical Immunologist. He is a co-founder and board member of the European Immunogenicity Platform (EIP), and member of multiple scientific societies including the European Bioanalysis Forum (EBF), American Association of Pharmaceutical Scientists (AAPS), German Society of Immunology (DGfI) and the German Society of Clinical Chemistry and Laboratory Medicine (DGKL). As a world-leading authority in the area of immunogenicity, he is invited to speak at numerous international scientific conferences and has authored multiple peer-reviewed scientific publications in journals and text books.
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