A model-based systems approach to pharmaceutical product-process design and analysis

This is a perspective paper highlighting the need for systematic model-based design and analysis in pharmaceutical product-process development. A model-based framework is presented and the role, development and use of models of various types are discussed together with the structure of the models for the product and the process. The need for a systematic modelling framework is highlighted together with modelling issues related to model identification, adaptation and extension. In the area of product design and analysis, predictive models are needed with a wide application range. In the area of process synthesis and design, the use of generic process models from which specific process models can be generated, is highlighted. The use of a multi-scale modelling approach to extend the application range of the property models is highlighted as well. Examples of different types of process models, model analysis and model generation are presented.