LAPSE:2023.36262
Published Article
LAPSE:2023.36262
Digital Twin Implementation for Manufacturing of Adjuvants
Poonam Phalak, Emanuele Tomba, Philippe Jehoulet, André Kapitan-Gnimdu, Pablo Martin Soladana, Loredana Vagaggini, Maxime Brochier, Ben Stevens, Thomas Peel, Laurent Strodiot, Sandrine Dessoy
July 7, 2023
Pharmaceutical manufacturing processes are moving towards automation and real-time process monitoring with the help of process analytical technologies (PATs) and predictive process models representing the real system. In this paper, we present a digital twin developed for an adjuvant manufacturing process involving a microfluidic formation of lipid particles. The twin uses a hybrid model for estimating the current state of the process and predicting system behavior in real time. The twin is used to control the adjuvant particle size, a critical quality attribute, by varying process parameters such as the temperature and inlet flow rates. We describe steps in the design and implementation of the twin, starting from the conception of the mechanistic model, up to the generation of its surrogate model used as state estimator, PATs and the setup of the information technology—Operational technology architecture. We demonstrate the performance of the twin by introducing different disturbances in the process and comparing the effect on the product critical quality attributes with and without the control of the digital twin. Finally, we showcase the digital twin implementation for the process in good manufacturing practice, through an engineering run, which demonstrated the robustness of the process when controlled by the digital twin.
Keywords
adjuvant particles, digital twins, Machine Learning, process analytical technology, process modeling, quality by design
Suggested Citation
Phalak P, Tomba E, Jehoulet P, Kapitan-Gnimdu A, Soladana PM, Vagaggini L, Brochier M, Stevens B, Peel T, Strodiot L, Dessoy S. Digital Twin Implementation for Manufacturing of Adjuvants. (2023). LAPSE:2023.36262
Author Affiliations
Phalak P: GSK, Rockville, MD 20850, USA
Tomba E: GSK, 53100 Siena, Italy
Jehoulet P: GSK, 1330 Rixensart, Belgium
Kapitan-Gnimdu A: GSK, 1330 Rixensart, Belgium
Soladana PM: GSK, 1330 Rixensart, Belgium
Vagaggini L: GSK, 53100 Siena, Italy
Brochier M: GSK, 1330 Rixensart, Belgium
Stevens B: GSK, Rockville, MD 20850, USA
Peel T: GSK, 1330 Rixensart, Belgium
Strodiot L: GSK, 1330 Rixensart, Belgium
Dessoy S: GSK, 1330 Rixensart, Belgium
Journal Name
Processes
Volume
11
Issue
6
First Page
1717
Year
2023
Publication Date
2023-06-03
Published Version
ISSN
2227-9717
Version Comments
Original Submission
Other Meta
PII: pr11061717, Publication Type: Journal Article
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LAPSE:2023.36262
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doi:10.3390/pr11061717
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Jul 7, 2023
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CC BY 4.0
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Jul 7, 2023
 
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Original Submitter
Calvin Tsay
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