Abstract
Antibody therapeutics are now well-established drugs for the treatment of various diseases. Factors that give rise to safety concerns arise through interactions between the body and the target protein, its biological properties, etc., which in turn depends on a variety of factors. One of these factors, the evolution of antibody engineering, tends to increase the efficacy and specificity of drug treatments, while increasing the complexity and difficulty of nonclinical safety studies. Therefore, pharmaceutical companies are trying to identify potential toxicities to patients by structuring nonclinical safety studies with creative ideas for each drug molecule. One of the gaps that tend to occur between reactions observed in patients and those detectable in nonclinical evaluations are immunological response differences. Because antibody drugs frequently involve reactions of the immune system, nonclinical safety studies must take such immunological differences into account to characterize toxicity. However, the estimation of the immunological responses and gaps often requires unique evaluation to each drug molecule because there are few standardized methods. In this presentation, I would like to focus on in vitro and in vivo immune-related assessments among the components of nonclinical safety studies. I would also like to discuss how we should make use of the information obtained in nonclinical immune-related assessments, despite the limitations of such assessments, and what challenges we should take up in the future.
