Confidently assess potential unintended binding and activity of biotherapeutics

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*註：影片長度約為1小時。

【Summary】

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.

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.

As one of the world’s most renowned companies for contract development and manufacturing, Lonza Pharma & Biotech is recognized for our reliable, high-quality services, our global capacity, our innovative technology platforms, and our extensive experience. From 2013 to 2016, our contributions supported 36% of launches with small-molecule breakthrough designation. In 2016 alone, we provided manufacturing services for more than 50 commercial molecules and conducted more than 250 development programs. We have helped launch pioneering autologous cell therapies.

Success for us is when you, as our partner, are fully satisfied. We continuously improve and innovate to meet your expectations and improve your chances of business success. Our broad capabilities span across biologics, small molecules, bioconjugates, and cell and gene therapies. We manage projects from pre-clinical stage through to commercialization, and our expertise covers both drug substance and drug product.

We believe that the best outcome – for you and for your patients – can only come as a result of a successful collaboration. Together, we can solve the next challenge and bring your next medicine to life.