Design of experiments and design space approaches in the pharmaceutical bioprocess optimization

Abstract

The optimization of pharmaceutical bioprocesses suffers from several challenges like complexity, upscaling costs, regulatory approval, leading to the risk of delivering substandard drugs to patients. Bioprocess is very complex and requires the evaluation of multiple components that need to be monitored and controlled in order to attain the desired state when the process ends. Statistical design of experiments (DoE) is a powerful tool for optimizing bioprocesses because it plays a critical role in the quality by design strategy as it is useful in exploring the experimental domain and providing statistics of interest that enable scientists to understand the impact of critical process parameters on the critical quality attributes. This review summarizes selected publications in which DoE methodology was used to optimize bioprocess. The main objective of the critical review was to clearly demonstrate potential benefits of using the DoE and design space methodologies in bioprocess optimization.

Keywords: Critical process parameters; Critical quality attributes; Design of experiments; Design space; Quality by design.