Presenter: PD Dr. Arno Kromminga, SVP & Chief Scientific Officer at BioAgilytix Europe
Host: Bioanalysis Zone
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 (as recommended in most US FDA immunogenicity guidance) can be easily reached. While it is exciting to have technical tools in hand to detect antibodies at very low concentrations, 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 discusses why careful and thorough data interpretation is needed, which takes into account the clinical manifestation of clinically relevant biomarkers (including PK). Dr. Kromminga also covers how the kinetics and type of antibody responses should be monitored to assess the risk of developing a treatment-emergent immune response, and finally, why post-approval patient monitoring should be mandatory.