PREFORMULATION

Preformulation refers to activities to determine the overall structure, stability and solubility of a new biotherapeutic drug candidate. Not only does this information serve to form the basis for subsequent formulation development, it can also be used to compare and select suitable candidates based on physicochemical properties, an activity sometimes called manufacturability or drugability.

Legacy has performed preformulation studies on a variety of proteins and peptides. We have used these data sets to make recommendations on what candidate molecules should be moved forward in development.

These initial assessments include the use of self-interaction chromatography (SIC) to evaluate the effects of solution conditions on self-association, which correlates with solubility and physical stability. This tool is the basis for solubility optimization work we have done for many clients.