(343h) Application Design of Experiments Methodologies in Pharmaceutical Development, Manufacturing, and Regulatory Assessment: Current Status, Opportunities and Challenges

Design of Experiments (DOE) is a well-established yet essential tool for Quality-by-Design (QbD) and Quality Engineering. It has been used across many industrial sectors for robust process and product design and optimization. In the past two decades, DOE has gained popularity during pharmaceutical development and manufacturing to expedite process and product development, ensure process robustness, and facilitate regulatory assessment at both pre-approval stage and post-approval stage. In particular, DOE is beneficial for complicated and advanced manufacturing processes. In this presentation, we will summarize current status, discuss opportunities and future challenges. In addition, we will share several case studies to illustrate some of frequently encountered issues that we have identified through pharmaceutical manufacturing process assessment in the past few years. This work will highlight the benefits of using DOE to develop and manufacture safe, effective, and high-quality medicines.