Analytical approaches to assess the degradation of therapeutic proteins

Publication Type:

Journal Article


Trac-Trends in Analytical Chemistry, Volume 49, pp. 118-125 (2013)



DOI Name (links to online publication)



analytical technique; chemical change; conformational change; degradation; drug; instability; product development; protein aggregate; protein degradation; therapeutic protein; field-flow fractionation; structural-characterization; secondary structure; mas


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. (C) 2013 Elsevier Ltd. All rights reserved.