Abstract: Scale-up of any pharmaceutical manufacturing process entails a skilful combination of art experience, science and engineering. Combination of a few well-established tools such as statistical methods (such as Design of Experiments (DOE)), PAT process monitoring tools, and quantitative modelling tools (such as CFD, DEM, PBE, etc.) may provide some advantages over the traditional methods of process scale-up in the pharmaceutical sector. Advancement in this direction could help to cause a paradigm shift from “Quality by Testing” to “Rational Process Design” within the spirit of the QbD initiative. Some open questions include but are not limited to: (1) how various tools aforementioned, if used individually, can be applied to or sustained for process scale-up; (2) how the pharmaceutical sector should develop a more innovative use of the existing tools. In this session, we seek papers that help to answer these two questions. Papers that focus on the use of quantitative tools (e.g. DOE, PAT, modelling, and theory) toward scaling-up pharmaceutical processes and linking to QbD implementation in the pharmaceutical sector are particularly encouraged. The session will provide a forum for open exchange of ideas or innovative use of tools for successful scale-up of the pharmaceutical processes. Papers concerning all areas of pharmaceutical scale-up, from small molecules to biologics, from drug substances to drug products, are being considered.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Systems and Process Design (10A)