Regulatory Forum Opinion Piece*

Le résumé fourni par la source

In the context of monoclonal antibody drug development, tissue cross-reactivity (TCR) studies are immunohistochemical (IHC) studies conducted on a broad panel of normal body tissues, using the antibody therapeutic as the primary reagent. The ICH S6 guidance states that these studies are performed to support investigational new drug (IND) or clinical trial applications (CTAs) for the initial dosing of human subjects for all antibody-based therapeutics. The purpose of TCR studies is, ostensibly, to inform investigators and regulators of potential target organs of toxicity based upon the binding of the therapeutic agent to tissue components. The value of TCR studies in predicting toxicity that would not otherwise have been detected in in vivo pharmacology and toxicology studies in pharmacologically relevant animal models has been a subject of debate for more than a decade. The history, challenges, and proper and improper uses of TCR studies were reviewed in this forum by Leach et al. in 2010. Coincident with this publication, a cross-industry survey on the utility of TCR assays in predicting human toxicity was separately published by a working group of the preclinical safety committee of the Biotechnology Industry Organization

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.