Analytical CMC Requirements for Biotech and Biosimilar Products: More Than Meets the Eye!”
Nadine M. Ritter, President and Analytical Advisor, Global Biotech Experts, LLC
The development and commercialization of a biotech or biosimilar product requires ten key analytical CMC studies. But biosimilar products have one additional major requirement: The analytical study conducted to demonstrate the degree of physiochemical and functional ‘similarity’ to the licensed reference product. This presentation will provide a technical, regulatory and quality overview of the analytical CMC studies performed for all novel and biosimilar biotech products, with justification and rationale for why – and when – they are done. It will then highlight the complex technical elements to be considered in the analytical comparison study unique to biosimilars. The types of analytical methods currently being used in these studies for characterization, comparability, release and stability testing of biotech/biosimilar products will be illustrated. Additionally, examples of operational factors that typically cause problems in analytical data will be shown. Finally, current and emerging ‘hot button’ issues for biotech/biosimilar products will be discussed.