Industry perspective of forced degradation studies to assess comparability of biopharmaceuticals

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Forced degradation, also known as stress testing, is used in pharmaceutical development to evaluate the comparability of biopharmaceutical products as per ICH Guideline Q5E. Despite its widespread use, detailed guidance on the design and interpretation of such studies is lacking.
The BioPhorum Development Group Forced Degradation Workstream recently conducted group discussions and a benchmarking survey to understand industry approaches for using forced degradation studies to assess the comparability of protein-based biopharmaceuticals.
This webinar will discuss forced degradation studies, analytical characterization, testing strategies, data evaluation criteria, and considerations for non-platform modalities. (e.g., non-traditional mAb).
Speakers 🗣️
- Goeran Huebner, ‪@boehringeringelheim‬
- Jamie Doyle, ‪@Regeneron‬
- John Campbell, ‪@GSK‬
- Jorge Alex Pavon, ‪@Merck‬
- Joshua Woods, ‪@pfizer‬
- Kasia Nowinski, SeaGen Inc
- Surinder Singh, ‪@BristolMyersSquibb‬
Chapters:
0:00 Webinar and BioPhorum introduction
3:30 Introduction to comparability
8:22 Factors that influence use of forced degradation studies
13:28 Forced degradation study design
18:37 Analytical characterization and testing strategy
25:56 Evaluation criteria
35:30 Challenges with non-platform biologic modalities
40:38 Conclusions
#forceddegradation #fds #biopharma #biopharmaceutics #BioPhorum #DevelopmentGroup