PREFORMULATION/DEVELOPABILITY

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 developability.

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.

For an overview of SIC, please see the review article we published (“Colloidal Behavior of Proteins: Effects of the Second Virial Coefficient on Solubility, Crystallization, and Aggregation of Proteins in Aqueous Solution”, Joseph J. Valente, Robert W. Payne, Mark Cornell Manning, W. William Wilson and Charles S. Henry, Current Pharm. Biotechnol. 2005, 6: 427-436).