AAPS Annual Meeting & Exposition

Degradation of proteins may occur during routine manufacturing and storage. Forced-degradation study (FDS) is usually used for the assessment of product comparability when there are significant changes to the manufacturing process that may alter the degradation pathways of the molecules. FDS is commonly performed to probe protein stabilities in exaggerated storage conditions in order to understand protein stability information in a short period of time. The results not only shed light on potential protein stability issues, but may reveal slight differences in the structure of the molecule that would not be otherwise detectable in a typical stability study. This session will go over general to strategy approaches from early clinical to commercial phases, such as designing increasingly leaner FDS studies based on the existing knowledge of product physicochemical characterization, critical quality attributes, and stability information, selecting correct analytical testing methods and technology, understanding external factors that can impact study results bias that cause artificial rate comparison failures, etc.

 7:30 a.m. – 8:45 a.m., Nov 13, Room 24