S50: Design of experiments for fermentation processes

Design of experiments (DOE) is a powerful and effective tool for modeling relationships in multivariable processes. While its application to industrial problems in manufacturing, process development, and research can be traced to the 1950s, its widespread use in the pharmaceutical and biotechnology industries is much more recent. In the last ten years, both the U.S. Food and Drug Administration and the International Conference on Harmonisation have suggested that DOE is an important methodology for solving quality issues.

This talk will focus on DOE fundamentals as they relate to fermentation processes and media design. Design issues affected by batch processes, difficult to change factors, scale-up, and nonlinear responses will be discussed.