Formulation and Quality – Biomolecular
2019 PharmSci 360
Kamal Egodage will discuss the importance of biomolecular characterization and when to start the characterization of the molecule. Kamal will show some examples to demonstrate the importance of the Developability Assessment of the molecules to reduce the risk and development time and cost of the molecule. Current Phase I Characterization methods and comparability requirements for a regulatory submission will be presented. Finally the presentation will connect the symposium speakers presentation to product development cycle.