Unexpectedly high baseline positivity in drug-naïve samples challenged ADC ADA assay development by inflating the assay cut point and reducing sensitivity. This presentation will show how root-cause investigations identified pre-existing anti-PEG IgM–mediated interference as the key driver and how a targeted mitigation strategy successfully restored assay performance and supported clinical readiness.
Learning Objectives:
Upon completion, participants will gain practical insights into overcoming assay interference and improving immunogenicity assessment in PEG-containing ADC programs
Upon completion, participants will be able to understand mechanism of pre-existing positivity in pegylated therapeutics
Upon completion, participants will be able to mitigate assay artifacts in ADA assays for pegylated therapeutics.
Upon completion, participants will be able to define strategies for meaningful data interpretation across clinical immunogenicity assessments for pegylated therapeutics.
