White Paper: Technologies to Measure Immunogenicity

An ADA case study of Infliximab

Assessment of immunogenicity is a regulatory requirement and is considered important to ensuring the safety and efficacy of therapeutic protein products such as monoclonal antibodies (mAbs). Assays for immunogenicity, measuring anti-drug antibodies (ADA) against a protein therapeutic, are generally immunoassays that measure the ability of antibodies in a patient serum sample to bind to (and for neutralizing assays, neutralize) the drug. There are a number different technologies employed with Enzyme Linked Immuno-Sorbent Assay (ELISA) and Electrochemiluminescence (ECL) technologies being two of the most conventional approaches. But which methods can be considered where ELISA or ECL techniques are not fit for purpose? As a consequence, new and emerging technologies must be assessed to ensure that the critical safety marker of immunogenicity assessment is being fully elucidated.

This White Paper provides an introduction to Surface Plasmon Resonance (SPR) as a immunogenicity technology and a case study that compares both SPR and a bridging ECL format to detect anti-infliximab antibodies. At Intertek, we work closely with you to deliver Total Quality Assurance through the best possible solutions for your studies, optimizing value for your immunogenicity programs.