“Forced degradation studies are an important part of the drug lifecycle process as they can inform many aspects of drug development,” said Jennifer Halley, Principal Scientist, Characterization, Analytical Sciences for Biologicals at UCB. “Many studies can be performed across different groups and phases of the molecule, and each phase can have different requirements, from research through to commercial. However, there is a lack of clear guidance on this topic.”
The studies are essential because companies need to fully understand their molecule, including how it reacts to different stress conditions. Many companies commit a huge amount of time and money to these studies and use a trial and error process to develop a standardized approach. Also, companies will often develop their approach in isolation, which may slow progress.
BioPhorum’s Forced Degradation workstream is helping to ease these burdens. The group has surveyed 12 member companies on their approaches and the key factors they consider when developing a standardized approach for the studies. The survey included more than 100 questions.
The team has reviewed the survey data and discussed the results, highlighting company practices, the challenges of different approaches and the purpose of forced degradation studies (see figure), etc. The analysis has prompted many valuable discussions between the team by highlighting common methods and innovative approaches, including how to use these studies to establish comparability.
The team is keen to share this learning and has written a paper, co-authored by 16 companies of the workstream, called an industry perspective on forced degradation studies of biopharmaceuticals: survey outcome and recommendations, which has been submitted for publication in the Journal of Pharmaceutical Science.
The team has recently started investigating how these studies drive understanding and decision-making in development. The above paper focused on the ‘what and how’ for forced degradation studies, the new topic focuses on ‘why and when’ the studies are run. The aim is to understand how the studies are used in decision-making through the different phases of development.
Sambit Kar, Principal Scientist; Head, Biophysics Center of Excellence, Molecular & Analytical Development at Bristol-Myers Squibb hopes that the team’s work will allow other companies to streamline their forced degradation approaches. “It is always beneficial to learn how others perform these studies. Elaine Stokes did a fantastic job as the BioPhorum Facilitator, and being involved has been a really positive experience”.