(438d) Global System Analysis of Interconnected Flow Sheet Models for Drug Product Manufacturing to Performance

Flowsheet models developed using gPROMS platform presents a holistic modeling and simulation approach to design drug product manufacturing processes. Often, these models involve estimation of several parameters using experimental data and measurements. Global Systems Analysis (GSA) is a powerful tool which can be used to identify the cardinal factors of the different parts of the process and their effect on critical quality attributes. In this presentation, we will share our recent experience using GSA through two case studies. First case study will focus on the development of API dry milling model and application of GSA in identifying inputs which are most influential for the model predictions. In the second case study, a comprehensive flowsheet that combines API crystallization, downstream solids operations and drug performance is thoroughly analysed using GSA.