Design Framework and Tools for Solid Drug Product Manufacturing Processes

This chapter presents a design framework and associated new assessment tools for solid drug product manufacturing processes. The framework describes the design flow in the form of an activity model. It highlights the interactions between simulation and experimental investigation, which address the difficulties related to the powder processes, e.g., heterogeneity. The activity model defines two newly developed mechanisms for conducting a simulation-oriented analysis. One is the superstructure-based economic assessment tool that can support the comprehensive generation of process alternatives. The tool uses stochastic simulation to consider various uncertainties in the design, such as undetermined process parameters, a potential change in market demand, or success/failure of the clinical development. The algorithm was implemented as an original software called “SoliDecision” by our research group. The other introduced mechanism involves developing practical knowledge of continuous technology obtained through experiments, e.g., challenges in scale-up and start-up operations, and key process parameters. These new mechanisms in the framework can effectively assist more rational and efficient simulation-based design of solid drug product manufacturing processes.