Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
Assessment of immunogenicity is a regulatory requirement and is 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 webinar provides an introduction to Surface Plasmon Resonance (SPR) as technology to measure immunogenicity and a case study that compares SPR and a bridging ECL format to detect anti-infliximab antibodies.Our Expert: Morgan Evans, Senior Scientist, Intertek Pharmaceutical Services.
Please fill in the form below to view our on-demand webinar.