Analytical approaches to assess the degradation of therapeutic proteins

• Main analytical techniques for degraded protein products are presented.
• Current analytical challenges are addressed.
• Analytical strategies during product development are suggested.

Physical and chemical instability of therapeutic proteins is one of the main concerns with the use of these drugs, because proteins are inherently unstable and protein degradation products can seriously compromise product efficacy and safety. Thus, it is crucial to choose the right analytical tools to characterize and to monitor protein degradation during development and commercialization of therapeutic protein products. This review aims to summarize the strengths and the pitfalls of current methods for assessing protein degradation, emphasizing the analytical challenges and discussing the most effective strategies during product development.