Applying in vitro immunogenicity assays to predict clinical immunogenicity

An immunogenicity risk assessment incorporates risk factors related to patients, products and the way the product is given to the patient. Prediction of the clinical impact of immunogenicity could be possible through a quantitative understanding of these risk factors and how the immune system operates. In vitro assays contribute to this quantitative understanding of risk and can be used during the discovery phase to inform risk mitigation strategies such as selection of lower risk leads.