There is huge promise in harnessing the immune system, but misdirecting this powerful response can have serious consequences for patients. Even minimal off-target binding can lead to drug development failures, therefore rigorous specificity analysis is critical for success. Long believed to be highly specific, recent data indicate that antibodies frequently (~25%) display cross-reactivity.

As a result, immunosafety assessments through specificity profiling is a regulatory requirement for monoclonal antibodies and other antibody-based biotherapeutics, an area where unfortunately, “standard” in vivo toxicology assessments might lack relevance.

In this webinar, we explore the challenges of comprehensively assessing the specificity profile when moving a candidate to first-in-human (FIH) studies, through the application of membrane proteome arrays and cell-based immunotoxicity assays. Case studies will highlight how these in vitro assessments add significant value by predicting risk early and how potential clinical safety issues could have been averted by such a comprehensive approach.