An industry perspective on common practice in forced degradation studies of biopharmaceuticals
Forced degradation studies (FDS) are a crucial part of the drug lifecycle process because companies need to fully understand their molecule, including how it reacts to different stress conditions.
However, there is a lack of clear regulatory guidance on how, when, and why to undertake FDS—only that they should be performed to understand a product further. This means many companies commit a huge amount of time and money to these studies and use trial and error to develop a standardized approach.
To gain an understanding of current industry approaches to FDS, the BioPhorum Forced Degradation Point Share conducted an inter-company collaboration exercise, which included a benchmarking survey and group discussions around forced degradation studies of monoclonal antibodies.
The results of this industry collaboration provide insights into the practicalities of these characterization studies and how they are being used to support the product lifecycle from innovation to marketed products. In this webinar, SME’s will take you through this global benchmarking survey from across 12 companies and present these as a guide to a common approach to FDS across the industry which can be used to guide the design of FDS based on CMC product life-cycle and biomolecule needs.