Fifty years of antibody therapeutics: From hybridomas to engineering for subcutaneous delivery

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Abstract：

The invention of hybridoma technology by Köhler and Milstein in 1975 helped launch the modern era of antibody therapeutics. Fifty years of advances in multiple fields, including disease biology, antibody engineering and biomanufacturing, have led to more than 200 approved antibody therapeutics. Historically, antibody therapeutics were primarily IgG, but a growing diversity of formats has emerged in recent years, including bispecific antibodies and antibody-drug conjugates. This presentation will highlight key advances that enabled this progress, including technologies for efficient production of bispecific IgG. The impact of successive generations of antibody therapeutics will be illustrated using HER2 targeting in oncology. The second part will focus on engineering antibodies for subcutaneous delivery. Subcutaneous administration can improve convenience and adherence for patients as well as healthcare efficiency. However, subcutaneous delivery often requires high-concentration formulations in which emergent properties such as high viscosity can become limiting. Recent studies demonstrate that both Fab-Fab and Fab-Fc self-interactions can contribute to IgG1 viscosity. Clinically validated Fc variants can sometimes reduce viscosity. This provides a practical strategy for designing antibodies well suited for subcutaneous administration.

Speaker Bio:

Paul J. Carter, PhD, is a Genentech Fellow in the Antibody Engineering Department at Genentech, Inc. In 2022, he was elected to the US National Academy of Engineering “for creating novel approaches to discovering and developing life-saving antibody therapeutics, including bispecific antibodies.” Carter co-invented antibody humanization technology used at Genentech to design nine approved antibody therapeutics that have been administered to more than 10 million patients worldwide. He and his collaborators also invented knobs-into-holes and common light chain technologies used by multiple companies in the design of seven approved bispecific antibodies.

Carter has 40 years of biotechnology experience, including more than 30 years at Genentech. His current research focuses on understanding antibody self-interactions at high concentrations to facilitate the engineering of antibodies suitable for subcutaneous delivery. Additionally, he researches nonclinical immunogenicity risk assessment and mitigation for antibody therapeutics. He is an inventor or co-inventor on 54 issued US patents and an author or co-author of more than 125 scientific publications, cited more than 30,000 times. Carter received his BA in Natural Sciences from Cambridge University and his PhD under Sir Greg Winter at the MRC Laboratory of Molecular Biology in Cambridge, followed by postdoctoral training with Dr. James Wells at Genentech.

Sponsor:

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