Immunogenicity of Therapeutic Proteins and the Assessment of Risk

Abstract

Nearly all therapeutic proteins induce an immune response. The immunogenic response may lead to complications such as skin reactions, anaphylaxis‐like reaction, transfusion reactions, and serum sickness due to immunogenic response to impurities and contaminants. This article focuses on risk analysis and management program for new therapeutic proteins and the factors influencing the probability of an antibody response.