The Relevance of Immunogenicity in Preclinical Development

The preclinical development of biopharmaceuticals or biotechnology-derived pharmaceuticals such as monoclonal antibodies, recombinant proteins, growth factors, etc. does not follow the “standard” rule as opposed to small molecules or new chemical entities. In addition, the biopharmaceuticals, being in essence large molecules, are susceptible to be targeted by the immune system eliciting an immunogenic reaction which can lead to adverse and even lethal and irreversible effects. This communication will discuss the cause of the onset of an immunogenic reaction and its clinical relevance when detected during the preclinical toxicity testing.