Designing non-clinical safety evaluation programmes for monoclonal antibodies: Recommendations and the way forward

Abstract

1. While the ICH S6 draft guideline provides excellent coverage of the general principles of safety evaluation of biotechnologically-derived products, there are several issues unique to monoclonal antibodies (MAbs) which require special consideration. These are: the pivotal role of in vitro tissue binding assays; the specificity of epitope binding; the pharmacodynamic effects attributed to Fc binding; the unique ability of MAbs to target a subset of cells; the possibility of transplacental passage; and the potential for long-term clinical adverse events.