Immunogenicity Testing and Predictions

Immunogenicity is an important aspect of biologic drug development as it can impact both the efficacy and safety of the drug. When the immune system recognises a biologic drug as a foreign substance, it may generate an immune response that leads to the production of antibodies. These antibodies can neutralise the drug, leading to a reduced therapeutic effect or cause adverse effects. The impact of immunogenicity on drug development and patient safety can be very significant, as it may result in drug failures, increased healthcare costs, and patient harm.

Understanding and predicting the potential of a biologic drug to induce an immune response is therefore a fundamental part of drug development. Immunogenicity testing can help researchers and clinicians understand how the immune system will react to a treatment, and can be used to identify potential safety concerns or optimise dosing regimens. The interplay between the adaptive and innate immune responses is complex, and the characterisation of immune responses against a drug requires a thorough understanding of the immune system and its components. Each project requires the selection of appropriate assays and a specific assay strategy, as many different drug and disease specific aspects need to be taken into account when investigating adverse immune reactions.