Manufacturing & Analytical Characterization
Thomas De Beer, PhD (he/him/his)
Professor
Ghent University
Ghent, Oost-Vlaanderen, Belgium
This presentation will focus on the latest developments and solutions in PAT for continuous drug manufacturing processes (small molecule oral solid dosage forms and biologics). Attention will not only be paid to the selection of the right sensors and overcomming the associated challenges (such as detection sensitivity, measurement robustness, data complexity, etc.), but also to level 1 control of the continuous production processes themselves (i.e., real-time automatic control + flexible process parameters to respond to variability in the input material attributes and process variations). All this will be substantiated with case studies on the production of oral medicines based on continuous direct compression, and case studies on the continuous production of freeze-dried biologicals. Finally, a vision will be presented about the future of this topic.