Webinar Recording: Clinical relevance of (unwanted drug-induced) immune responses

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.

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See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.

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Cell-Based Assays

Learn how BioAgilytix provides the specialized large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay (CBA) requirements.

Pharmacokinetics (PK) Services

See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.

Case Studies

Learn why we’re a trusted partner to 22 of the top 25 global pharma and biotech companies.

Tell Us About Your Project

What are your specific assay needs? Let’s schedule a conversation to review your
questions and requirements with one of our scientists.

SPEAK TO A SCIENTIST
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