Monitoring Antibody Immune Responses against Biotherapeutic Drugs

Advances in the development of biotherapeutic proteins, such as monoclonal antibodies, enzymes and toxins, bode well for future improvement of human health. Drug safety and efficacy are key concerns for the manufacturer during the long, complex and costly development process. In addition regulatory agencies now expect that immune responses caused by drug treatment are monitored during preclinical development and clinical trials. Immune responses leading to the generation of anti-drug antibodies (ADA) can cause adverse events, but the most common problem is loss of efficacy, when ADAs bind the drug and neutralize its activity or speed up its biological elimination.