Design of Experiments (DoE) is a statistical methodology used to systematically evaluate the effect of multiple process parameters and their interactions on defined output responses or CQAs. In bioprocess development, DoE enables efficient process characterization, optimization, and robustness testing by reducing the number of experimental runs required compared to one-factor-at-a-time approaches. It is a key tool in establishing the design space and control strategy as described in ICH Q8 guidelines.
