This session will discuss novel approaches using PAT to monitor, model, and/or control a chemical or biological processes. Papers discussing PAT applications at the pilot plant or manufacturing scale will also be considered. The PAT initiative encourages industry to introduce on-line, in-line, or at-line analytical tools to identify key process parameters that affect product quality through the use of scientifically based process design and statistical tools (“Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance,” September 2004)

Pharmaceuticals