With these degradation mechanisms, we now have a model to assess how the sample will behave under extreme conditions such as may be met during failures of shipment and packaging or other stages from initial manufacture through to final handling at the patient location.
Furthermore, with the knowledge of the structure of any product degradants that are generated through the different forced degradation processes, manufacturing procedures can be adjusted to improve product quality.
Forced degradation studies can also serve to identify potential points of fragility of the product to external conditions, which can be further examined in controlled stability investigations.
Samples that have been forcibly degraded are useful to employ during qualification and validation of method development procedures (this is noted in ICH Q2(R1) guidelines on validation of analytical procedures), where they can serve to demonstrate specificity of the method under evaluation.
Finally, forced degradation and the idea of assessing the similarity of degradation pathways as part of a biosimilar comparability exercise is mentioned in the FDA and EMA biosimilar comparability guidelines (1,2).