Modelling continuous pharmaceutical and bio-based processes at plant-wide level: A roadmap towards efficient decision-making
PEDRAM RAMIN1, SEYED SOHEIL MANSOURI1, ISURU A. UDUGAMA1, BRAHIM BENYAHIA2, KRIST V. GERNAEY1
1. Process and Systems Engineering Centre (PROSYS), Department of Chemical and Biochemical Engineering,
Technical University of Denmark, Lyngby, Denmark
2. Department of Chemical Engineering, Loughborough University, Leicestershire, United Kingdom
Abstract
The importance of developing simulation models for decision-making in pharmaceutical and bio-based production processes is elaborated in this article. The advantages of modelling continuous processes are outlined and certain barriers in this regard are identified. Although there have been some advancements in the field, there needs to be a larger international collaboration in this regard for providing reliable data for model validation, for development of generic model-based frameworks and implementing them in computer-aided platforms in the form of software tools.
INTRODUCTION
Tight regulations together with rising cost of the R&D and production have been a driving force for the pharmaceutical and bio-based industries to seek and adopt more flexible and viable synthesis and purification alternatives, reliable Process Analytical Technologies (PAT) and robust control and monitoring strategies. Many pharmaceutical and bio-based production processes (where upstream is a fermentation or cell culture) are operated in batch mode, and producing high value products from relatively low value raw materials. These processes have typically been scaled up from lab/bench scale with no particular attention paid to improving process throughput and efficiency, recovery or decreasing the overall materials and energy consumption due to the lucrative economics. However, the dynamics of pharmaceutical and bio-based manufacturing are evolving rapidly. Firstly, the costs related to bringing in new drugs have been increasing over time (1) while the time required to get a drug approved is considerable. In addition, generic pharmaceutical and bio-based manufacturing introduces increased competition between various stakeholders by drastically lowe ...
