Bioanalytical Principal Investigator Immunologix Laboratories POLK CITY, Florida
As complexity of drug modalities expands, managing different types of immunogenicity interferences is required to deliver assays that detect clinically meaningful responses. A robust understanding of drug modality, mechanism of action, and associated biology prior to method development is critical for development of appropriate strategies to mitigate the interferences. Here we present five case studies where we observed unusual levels of biological interference that included interferences associated with pre-existing antibodies, circulating target, prior therapies in the target patient population, as well as unknown interferents in the sample matrix. We adopted different mitigation strategies to overcome these varied interferences. In each case several approaches were evaluated, and ultimate successful mitigation solutions are presented.
Learning Objectives:
Upon completion, participants will be able to characterize and mitigate various forms of immunogenicity interference.
Participants will gain valuable insights into the importance of a strong scientific understanding to identify the presence and impact of immunogenicity interferences.
Participants will better understand how to ensure the integrity of the true immune response when interference can be eliminated or tolerance improved using various sample pre-treatments described here.
