Forced degradation, also known as stress testing, is used throughout pharmaceutical development for many purposes, including assessing the comparability of biopharmaceutical products according to ICH Q5E. These formal comparability studies investigate the potential impacts of manufacturing process changes on the quality, safety, and efficacy of the drug.
Unfortunately, despite the wide use of forced degradation in comparability assessments, detailed guidance on the design and interpretation of such studies is scarce.
BioPhorum’s Forced Degradation Workstream recently conducted group discussions and a benchmarking survey to understand current industry approaches for using forced degradation studies to assess the comparability of protein-based biopharmaceuticals.
Published in the Journal of Pharmaceutical Sciences, this article is for anyone in biopharmaceutical development who might use force degradation in their comparability studies – this is very common, but each company does it differently. It includes results from a cross-industry survey that compares and contrasts how companies carry out such studies. It will help practitioners perform their studies and help regulators to interpret them.
The results provide insight into the design of forced degradation studies, analytical characterization and testing strategies, data evaluation criteria, and some considerations and differences for non-platform modalities (e.g., non-traditional mAb).
The article is unique in capturing a snapshot of how companies approach the topic. Understanding where we are today will guide where we go tomorrow.