This talk will summarize results from a three year investigation that was performed under a US FDA-BAA sponsored project (Grant 1U01FD007758-01). Over the past decade, biopharmaceutical manufacturers and the regulators have come to some level of consensus on a number of typical critical quality attributes that exist for a biotherapeutic product and the various analytical methods that can be used to monitor them. Demonstration of analytical and functional similarity of a biosimilar product to the respective innovator product is the foundation of a biosimilar manufacturer’s regulatory filing. A key challenge when performing these activities is that the excipients and species in the formulation interfere with the typical set of analytical and functional tools that are otherwise routinely used for characterization and comparability of drug substances. As a result, the biosimilar manufacturers resort to a variety of approaches to isolate the biotherapeutic protein from the drug product formulation but this introduces an uncertainty about the impact of this isolation on product degradation and the results obtained thereafter. This talk will discuss the various challenges that a biosimilar manufacturer faces when performing analytical and functional comparability assessment of biosimilars. These include role of extraction of product from the drug product and interference of the various excipients in analysis using the various tools that are routinely used in this analysis.
Learning Objectives:
How does extraction of a protein from drug product impact protein structure?
Do excipients interfere with analytical and functional methods that are routinely used for analytical and functional comparability assessments
Are their analytical approaches that can effectively manage excipient interference?
