Mechanistic Fermentation Models for Process Design, Monitoring, and Control

摘要

Mechanistic models require a significant investment of time and resources, but their application to multiple stages of fermentation process development and operation can make this investment highly valuable. This Opinion article discusses how an established fermentation model may be adapted for application to different stages of fermentation process development: planning, process design, monitoring, and control. Although a longer development time is required for such modeling methods in comparison to purely data-based model techniques, the wide range of applications makes them a highly valuable tool for fermentation research and development. In addition, in a research environment, where collaboration is important, developing mechanistic models provides a platform for knowledge sharing and consolidation of existing process understanding.TrendsThe Quality by Design (QbD) and process analytical technology (PAT) initiatives have encouraged the development of more advanced monitoring and control methods.Modeling is one method of ensuring that there is an understanding of how the critical process parameters affect the critical quality attributes, therefore ensuring the quality of the product.Mechanistic modeling is proposed as a very flexible modeling tool that may be applied at multiple stages of the process development pathway without significant adaptation of the model.]]>