Join the latest webinar on 29 February – An industry perspective on the use of forced degradation studies to assess comparability of biopharmaceuticals
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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, there is a lack of published material on how to approach forced degradation as it applies to comparability and, more importantly, there is a lack of agency guidance on the best way to carry out those studies.
This is why BioPhorum’s Development Group Forced Degradation Workstream held group discussions and a benchmarking survey to understand current industry approaches. The results have been published in An industry perspective on the use of forced degradation studies to assess comparability of biopharmaceuticals.
“It’s a good starting point for scientists in the industry, especially for a company entering the field who is not sure how to approach it,” said Jamie Doyle, Staff Scientist at Regeneron. “Having the industry perspective from a lot of companies, both big and small, gives you a good benchmark of how to approach these types of studies.”
Published in the Journal of Pharmaceutical Sciences, the article is for anyone in biopharmaceutical development who might use forced degradation in their comparability studies – this is very common, but each company does it differently. The paper 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 article provides insights 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).
John Campbell, Scientific Leader and GSK Fellow at GSK, said, “I hope the paper will improve alignment between companies, improve the speed with which these studies can be done, the quality of the studies, and provide benefits to the patient in terms of supporting drug development.”
The paper is unique in capturing a snapshot of how companies approach the topic. Understanding where we are today will guide where we go tomorrow.
For more information, contact Elaine Stokes, Senior Global Change Facilitator, at firstname.lastname@example.org