Higher Order Structure

Protein higher-order structure (HOS) and dynamics are essential to protein function. For protein-based therapeutic products, HOS is a critical quality attribute which needs to be monitored to ensure safety and efficacy of drug products. HOS can be monitored by a multitude of biophysical and structural characterization tools. The choice of the appropriate biophysical method and the method development and qualification strategies to characterize and control HOS at different stages of the product lifecycle are a matter of interest and debate for a wide range of audiences.