Application Note: Automation of a Homogeneous Proximity Assay for Immunogenicity Testing of Biological Drug Products
6 June 2013
Several challenges have surfaced during clinical evaluation of biological drug products due to a commonly associated immune response in patients. Anti-drug antibodies (ADA) are known to be frequently generated during administration of humanized monoclonal antibody therapeutics. These ADAs are nearly indistinguishable from antibody drug therapeutics thus requiring robust selective methods to determine the extent to which they impact safety and efficacy during treatment. This application note presents a homogenous, bridging assay that can be used to detect ADAs and compares it to ELISA.