[Whitepaper] How changes in drug substance processes can affect formulation

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: its purity, potency, by-products, particle size distribution, morphology (crystal shape and structure), and rate and extent of dissolution.

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.

DS characterization is critical to DP formulation but characterization and formulation are often not integrated during drug development. This creates needless difficulties because if DS chemists and DP formulators collaborate on a formulation development strategy for early Phase I first in-human clinical studies, they can save time, money, and avoid rework.

Please download this whitepaper to learn more.


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