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.
BioPhorum’s Forced Degradation Point Share is helping to ease these burdens and has written An Industry Perspective on Forced Degradation Studies of Biopharmaceuticals: Survey Outcome and Recommendations. This has been published in the Journal of Pharmaceutical Science and, for a short time only, the full article is available here.
The paper is based on a survey of 12 member companies on their approaches and the conditions they use when developing a standardized approach for FDS.
It is the first time cross-industry data has been gathered to provide a greater understanding and common practice for FDS.
The paper highlights the purposes and the FDS used by companies followed by a table of current industry practice. It can be used by industry to review its FD practices, or as a general guide for planning, setting up and executing FDS at various stages during the biotherapeutic lifecycle.
It has already prompted many discussions within the Point Share about common methods and innovative approaches, including how to use FDS to establish comparability.