Biotherapeutics Analytical Summit 2013

Part One March 11-12, 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.

In Part Two March 13-14, FDA representatives and experts present regulatory expectations in the US and Europe for change implementation and for biosimilars regarding the product and the process. Part Two also presents analytical controls focusing on quality targets, and analytical tools and strategy. Case studies cover all stages of development from early development to commercial stage and include clinical comparability with PKPD, biophysical and biochemical assessments, functional tests and immunogenicity for a range of biotherapeutics including biosimilars.