Bioassays 2013: Scientific Approaches & Regulatory Strategies
04 Mar 2013 - 05 Mar 2013 - Rockville, MD, USA
In a few short years, "Bioassays" has quickly established itself as a unique opportunity for participants to gain current regulatory and industry insight regarding bioassays. Bioassays are part of the foundation upon which analytical control strategies for biologics and other complex molecules are built. The ability of an assay to characterize and demonstrate biological activity is essential. Biologic drugs may have complex and/or multiple modes of action. Companies are continuously challenged with developing assays that are biologically relevant for the analysis of these different mechanisms. These methods are used for lot release, stability, and/or characterization. Therefore, these methods must be robust and in many cases, suitable for a QC lab.