This webcast features: Jason Sterling, Principal Scientist and Project Director, Analytical and Formulation Resources, and John Rockwell, Group Leader, Catalent Pharma Solutions
Biophysical characterization is critical to understand the make-up and behaviors of biologic therapies and vaccines both early in development and throughout the manufacturing scale-up process. As biologics become more complex in structure, and as scientists improve their understanding of the effects of structure on stability, efficacy, safety, etc., there is a need to develop new and improved analytical methods to characterize biologic products. During this presentation, experts will discuss the latest challenges in biophysical characterization and will present solutions to overcome these challenges, including:
- A method to evaluate extractables and leachables in order to measure residual-free toxins during antibodyâ€“drug conjugate (ADC) development
- Three common techniques (glycopeptide analysis, N-glycan analysis, and sialic acid analysis) that are used to identify, characterize, and quantitate sialic acids on biologics molecules
- Additional drivers of new method development for biophysical characterization.
Watch the recorded webcast now.