Immunogenicity of therapeutic proteins

Abstract

The era of the medical application of proteins started at the end of the nineteenth century when animal sera were introduced for the treatment of serious complications of infections such as diphtheria and tetanus. The high doses used, the general lack of quality controls and a regulatory system, and the impurity of the preparations led to many serious and sometimes even fatal side effects. Many of the problems were caused by the strong immune response these foreign proteins induced, especially when readministered. People who had been treated in general had a warning in their passports or identification cards to alert physicians for a possible anaphylactic reaction after rechallenge with an antiserum. Also serum sickness caused by deposits of antigen-antibody complexes was a common complication of the serum therapy.