Quality By Design in Integrated Processes: From Drug Substance to Drug Product

This paper will present a methodology that can be used when applying Quality by Design (QbD) in consecutive process steps, namely when integrating drug substance and drug product processes. It will show how process parameters and material attributes can be effectively combined expanding the overall design space and hence process flexibility in both cases. This work will also present a comparative study between similar processes using Quality by Design and Traditional approaches. Process metrics and performance indicators have been measured after extensive exposure of both processes to manufacturing campaigns. QbD based process showed for all parameters a significant improvement regarding the traditional approach. The higher development costs of the QbD based approach were rapidly covered by the improved performance at commercial manufacturing stage.