Analytical Characterization 2013

Part One presents analytical case studies aimed at developing well characterized biotherapeutics with clearly defined quality features and reduced CMC liabilities. It covers higher order structures, sequence variants, impurities, charged isoforms, glycosylation and hot spots for stability, PK and biological activity for a range of products. The wide range of analytical technologies presented includes mass spec, proteomic approaches, and an innovative automated western blot technique. The functional characterization session includes bioassays for potency and binding, and a report of required standards from the USP.