Changes in the Drug Substance (DS) process as it scales up can affect the Drug Product (DP). As processes change, many properties of the DS can also change. Therefore, as DS manufacturers evaluate and optimize the synthetic route, process conditions, crystallization solvents, etc., they must understand and track these changes, and discuss them with DP formulators to anticipate challenges in formulation.
Learn how collaboration between DS chemists and DP formulators on a formulation development strategy can save time, money, and avoid rework.
Author: Anil Kane, PhD, MBA, Global Head of Technical and Scientific Affairs, Formulation, Patheon