Application Notes on Secondary and High-Order Structure

BioPharmaceutical Formulation

Formulation of protein-based drugs often requires processes such as lyophilization or spray-drying. However, it has been shown that the freezing and drying steps involved in lyophilization could lead to protein unfolding. This unfolding of the native structure leads to an incomplete recovery of activity and results in aggregation and poor storage stability. These problems are often discerned through tedious and time-consuming measurements of activity or through detailed structure analysis. New and faster analytical techniques are needed in order to accelerate the development of protein formulation.