Optimal Formulation Development

Formulation plays a pivotal role within the drug development process. Encompassing a spectrum of activities – from developability assessment and buffer optimization to dosage form studies and compatibility testing with administration devices and storage containers – formulation development represents a strategic investment in the early stages. This investment yields significant benefits throughout the development pipeline.

A robust developability program facilitates the identification of potential risks and liabilities associated with a drug candidate's physicochemical properties. By generating critical data on factors like specificity, potency, safety, pharmacokinetics, and manufacturability, such programs contribute to informed decision-making. Early assessment allows for targeted modifications to the drug design, mitigating risks and aligning the candidate with the target product profile (TPP) before incurring the higher costs associated with later-stage development.

View the webinar below to delve into the integration of formulation development within the broader drug development landscape and learn about the importance of de-risking drug candidates through data-driven lead selection processes. Gain valuable insights into the development of a phase-appropriate de-risking strategy that will guide the selection and application of suitable formulation processes to achieve alignment with the optimal target product profile.