Forced degradation studies: current trends and future perspectives for protein-based therapeutics

ABSTRACT

Introduction: Forced degradation (FD) studies (stress testing) are an integral part of pharmaceutical product development.

Areas covered: The design and execution of these studies require thorough planning and coordination through the various stages of development as well as post-approval commercial operations. This is particularly crucial in the case for protein-based therapeutics due to complexity of the molecular structure as well as the potential influence of the manufacturing process on product attributes. Often, FD study applications are linked to specific product development in a phase-specific and case-by-case manner with differing purposes and focus.

Expert commentary: This paper summarizes some key FD approaches commonly employed in the industry and provides considerations on study design strategies and database management through the course of the product lifecycle.

KEYWORDS:

• Comparability studies
• forced degradation
• stress testing
• protein stability

Acknowledgments

The author thanks Dr. Hubert Scoble for critical review of the manuscript.

Declaration of interest

The author is an employee of Sanofi. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.