Structural characterization is the cornerstone of understanding your molecule. The analyses described in the ICH Q6B guidelines are designed to assess many different facets of biopharmaceutical structure ranging from the primary sequence level, such as peptide mapping, to assessments of post translational modifications and glycan characterization, higher order structure (secondary and/or tertiary structure), physicochemical properties and aggregation. This is the best way to prove that your molecule has the expected structure under “ideal” or “normal” conditions. However, consideration also needs to be given to how the molecule behaves under extreme conditions and this is where Forced Degradation studies come in.
What is Forced Degradation?
During a Forced Degradation study, mechanisms are used to purposefully degrade the sample in order to investigate what degradants are produced and to understand the chemical breakdown pathways that the molecule takes when it is subjected to these stresses.