(107b) A Pharmaceutical Engineering Process/Product Life-Cycle Approach to Drug Product Development and Manufacturing

Jose C. Menezes, Sephan Sacher, Georg Scharrer, Stefan Leitgeb, Christine Voura, Simon Fraser, Johannes Khinast

Research Center Pharmaceutical Engineering GmbH, A-8010 Graz, Inffeldgasse 21a/II, Austria

Drug product design, development and manufacturing involve different goals and use different tools throughout product and process engineering life-cycle. At the formulation design stage a materials science-based approach should dominate. During development and especially later during manufacturing (continuous or batch) a process-centered perspective prevails.  At the end of processing a drug product of required purity, safety and efficacy should be obtained. A stronger link between the different goals throughout those life-cycle stages must be established to ensure modern and competitive pharmaceutical manufacturing. 

PAT monitoring tools, however, when used as such (i.e., as process state estimation and not as in-process quality controls of specific parameters) are process-centered but can be used to link process to product (viz., process  parameters and attributes to product critical quality attributes).  Here we discuss several case-studies involving RCPE’s recent activities, highlighting the use of advanced simulation and innovative PAT tools in formulation design, process development and different operational requirements for routine manufacturing within the QbD context.  A balance summary perspective of where the area is evolving into after a decade of PAT and QbD will be given.