CHI Immunogenicity Summit 8 October 2020 Presentation
Optimizing ADA assay tolerance towards drug product using automated acid dissociation in an automated, microfluidic format
Recently, regulatory agencies have lowered sensitivity requirements for anti-drug antibody (ADA) bioassays. Reaching lower sensitivity levels while maintaining drug tolerance may necessitate lengthy acid dissociation pre-treatment steps, affecting assay quality. We present miniaturized, microfluidic ADA immunoassays with an automated acid dissociation step that demonstrate high sensitivity, high-quality, and drug-tolerant assays.