Drug Product, Fill-Finish & Formulations
A Practical Approach for Assessing the Impact of Visible and Ultraviolet Radiations on Biomolecules
While biomolecules are routinely exposed to ICH Q1B exposure levels as part of forced degradation studies, the primary goal of these studies is to gain an understanding on the degradation profile and demonstrate that appropriate analytical methods have been developed to elucidate the various degradation pathways. Since, most of the biomolecules contain light-sensitive amino acids in their chemical structures, exposing them to ICH Q1B conditions may lead to significant degradation (i.e. aggregates). Presented in this talk is a practical approach for assessing the impact of both the visible and ultraviolet light radiations on biomolecules and eventually developing a science-based control strategy for light exposure during the drug product manufacturing process.