Characterization of Biologically Derived Drug ProductsThis project will develop and evaluate analytical methods to assess physicochemical attributes of biologically derived drug products that affect function.
ON TRACKON TRACK1. Identify methods that characterize molecular structure (primary, secondary, tertiary), post translational modification and stability (aggregation/degradation)6/30/2011Completed6/30/20112. Select model systems representing drug classes to assess suitability of methods12/31/2011Completed12/31/20113. Establish analytical method capabilities to measure potential critical product quality attributes9/30/2013On Track4. Determine physicochemical comparability (define sameness)9/30/2013On Track5. Document benefits and limitations of methods and develop publications12/31/2013On Track