Senior Principal Scientist Genentech South San Francisco, California
Although PEGylation has been used in large molecule development to increase half-life, a holistic overview of special bioanalytical strategies and challenges in PEGylated drug development is still lacking. The presentation will take a branched PEGylated biological molecule as a case study to share our experience in bioanalytical strategies of measuring protein concentrations, anti-drug antibodies to both protein and PEG portions, as well as determining PEG concentrations for safety concern. The presentation will demonstrate how to use innovative and fit-for-purpose approaches to successfully overcome challenges due to PEGylation. The discussion triggered by the presentation will help bioanalytical scientists to learn from each other and come up with harmonized bioanalytical strategies in PEGylated drug development.
Learning Objectives:
Gain experience in bioanalytical strategies, challenges and solutions in PEGylated drug development.
Learn bioanalytical strategies and methods for measuring protein concentrations, anti-drug antibodies and PEG concentrations to support PEGylation drug development
Apply strategies and key learnings from the presentation to any other PEGylated molecules.
