Design of Experiments to Accelerate Formulation Development of Complex Modalities

The development of complex biologic modalities presents significant formulation challenges due to their intricate composition, stability constraints, and sensitivity to process parameters. Traditional formulation approaches often rely on trial-and-error methods, which are time-consuming and resource-intensive. Design of Experiments (DoE) provides a systematic, data-driven approach to optimizing formulations by using critical quality attributes and process parameters that influence product stability.
This talk will explore the application of DoE in accelerating formulation development for complex biologics. Key topics will include experimental design strategies, selection of independent variables, and response surface methodologies to enhance stability, efficacy, and manufacturability. Case studies will highlight how DoE enables rapid iteration, robust data generation, and predictive modeling to streamline development timelines and reduce formulation risk.
By integrating DoE into formulation workflows, researchers and product developers can efficiently navigate the complexity of modern molecules and drug delivery systems, ultimately advancing innovative therapies from bench to clinic more effectively.