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

Abstract

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