Role of PAT and QbD in Biologic Drug Production Training Course :

PAT &ndash; Process Analytical Technology is a risk management approach for ensuring consistent production of prescription drugs within a well-defined quality envelope. QbD &ndash; Quality by Design &ndash; encompasses PAT and uses its concepts across a much wider front; from drug discovery and development to the patient. Both PAT and QbD are mainstays of 21st century good manufacturing practice.<br><br> This course establishes an operating baseline for biologic PAT programs, using the outcomes of successful small-molecule PAT efforts. Course modules include an analysis of biologic business drivers and timelines, PAT and QbD principles and their relationship to the ICH &ndash; International Conference on Harmonization.<br><br> The course includes sections on biologic unit operations, in-process testing and supra-process testing - including the use of dynamic test technologies to support mainstream production methods.