Confidently assess potential unintended binding and activity of biotherapeutics

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.

Featured Speakers

Rachel Fong
Alliance Manager
Integral Molecular

Rachel Fong is Integral Molecular’s Senior Alliance Manager, with over 10 years of experience at the company. Rachel manages relationships with customers, collaborators, and partners, for MPA projects. As a founding member of the scientific team that launched this platform, she brings a unique perspective that helps guide partners from initial discussions to successful project completion. Rachel joined Integral Molecular in 2010 and is a co-author on over a dozen publications.

Dr. Noel Smith
Head of Immunology, Early Development Services
Lonza Biologics

Noel completed his PhD and subsequent post-doctoral studies at the University of Cambridge in the field of metabolic disease. Noel joined Lonza in 2009 and was involved in the setup of the human primary cell-based assay platform and now heads the Immunology group which develops assays to screen products for immunogenicity and immunotoxicity risk.

Date:  Monday, December 6, 2021
Time:  11am ET / 8am PT
Duration:  1 Hour

Register now for this webinar

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