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Model-based Optimization in Pharmaceutical Technical Operations – Yield Measurement and Increase in Roche's Parenterals Production Kaiseraugst

2012; Elsevier BV; Linguagem: Inglês

10.1016/b978-0-444-59519-5.50116-7

2543-1331

Hirokazu Sugiyama, Rainer Schmidt,

Manufacturing Process and Optimization

In this work, we present an industrial application of process modeling and optimization methods for increasing product yield in Roche's new Parenterals production Kaiseraugst (PKau) in Switzerland. This facility receives Active Pharmaceutical Ingredients (APIs) and produces high-value drug products in injectable forms such as liquid vials. We have developed a mass balance model, which can prioritize various causes of API losses over the entire processes of PKau. The model is directly linked with the Manufacturing Execution System (MES) which provides the material flow data of a batch on a paperless manner. Based on the suggested priority, counter measures have been implemented to improve the product yield, and a higher level of manufacturing performance has been achieved already during the facility start-up.