(105f) Process Modeling and Design in Pharmaceutical R&D

A process model can be defined as a mathematical description of a process, often based on chemical, physical, or engineering principles, used to understand and predict performance within a range of parameters. Typically derived from experimental data, the process model requires a strategic experimental plan for efficient use of resources as well as the mathematical analysis to compute a statistically adequate model. The presentation will provide a perspective of process modeling approaches being employed in development of API. Specifically a Quality by Design (QbD) application using an example from a recent API manufacturing process will be described. The work includes a risk assessment and multivariate design supporting the example of design space. Details of reaction kinetics and Design of Experiments (DoE) will be presented in the context of leveraging the synergy of Chemists and Chemical Engineers in Process Development.