Forced degradation of biopharmaceuticals: Protein stress testing

Forced degradation is defined as the intentional degradation of a biotherapeutic to an appropriate extent by means of various stressing agents. The overall aim of such forced degradation (also known as stress studies) is to understand how a biotherapeutic may undergo degradation, whether this occurs during or following manufacture. More specifically, forced degradation aims to accelerate the chemical and physical changes of a biopharmaceutical molecule in order to determine the mechanisms of degradation, depending on the various stresses applied to it. Developing an understanding of the potential routes for degradation early in the life cycle of drug development can help create an understanding of any potential molecule liabilities and provide an opportunity to understand the risk represented to the quality, safety or efficacy of the product.