Doctoral dissertation Niels Nicolaï - Supervisory process monitoring, identification and control for continuous pharmaceutical wet granulation

PhD Jury

BIOMATH is proud to announce that Niels Nicolaï successfully defended his Doctoral Thesis. In 2013 Niels graduated as a Master of Science in Bioscience Engineering with a specialisation in Chemistry and Bioprocess Technology. At that time, he became fascinated by the scientific fields of mathematical modelling and control for the bioprocess industries. Given the opportunity, Niels started his doctoral research at the Laboratory of Pharmaceutical Process Analytical Technology and the BIOMATH research group of Ghent University. Funded by the Janssen Pharmaceutical Companies of Johnson & Johnson, Niels engaged in an international research project aimed at the mathematical modelling and control of a novel continuous manufacturing line for the production of pharmaceutical tablets. He (co-)authored several internationally peer-reviewed journal articles as well as a book chapter. Besides performing valuable research, Niels also taught classes on data acquisition and developed multiple laboratory automation systems.

Doctoral Thesis

Title: Supervisory process monitoring, identification and control for continuous pharmaceutical wet granulation

Abstract: The pharmaceutical industry is facing some major challenges in the 21st century. Most notably are the decrease in research and development productivity and the ever increasing competition among pharmaceutical companies. This triggered the industry and its regulators to rethink the drug development and manufacturing business. One particular measure is the aim for faster drug development using flexible manufacturing technologies based on fundamental scientific process understanding.

The objective of this doctoral research was to investigate the opportunities of real-time drug product monitoring combined with automatic process control for the continuous manufacturing of pharmaceutical tablets. First, an existing powder-to-tablet manufacturing line was evaluated in terms of more advanced process monitoring and control opportunities. Next, it is was illustrated how a combination of real-time product analysers can be combined with mathematical models to monitor and predict the chemical and physical state of the intermediate wet granules. These tools were subsequently applied in automatic control loops in order to maintain the desired chemical composition and physical size of the manufactured granules.

Based on the findings of this doctoral research, a more detailed understanding is provided regarding the challenges and opportunities of automatic process control for continuous tablet manufacturing.


Ghent - Belgium
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