Projektbeschreibung
Die Produktion biologischer Arzneimittel modernisieren
Biologische Arzneimittel sind im Gesundheitswesen von entscheidender Bedeutung. Das wurde durch die zentrale Rolle von mRNA-Impfstoffen in der Pandemie deutlich. Die Herstellung biologischer Arzneimittel beruht jedoch auf veralteten Batch-Produktionsmethoden und empirisch abgeleiteten Entwicklungsverfahren. Finanziert über den Europäischen Forschungsrat soll im Projekt CoDiBio ein digitaler Zwilling geschaffen werden, der erstmals eine kontinuierliche, integrierte und vollständig digitalisierte Anlage für die mRNA-Produktion darstellt. In der Anlage werden innovative hybride Modelle zur Echtzeitüberwachung und -kontrolle, zum Wissenstransfer, der Szenarioanalyse und der Versuchsplanung eingesetzt. Die Projektaktivitäten fließen auch in andere neue Verfahren ein, wie die Strömungschemie für nachhaltige Katalyse und Mikrofluidik für die kontrollierte Synthese von Nanomaterialien.
Ziel
Biopharmaceuticals are essential for the medical treatment of diseases like immune deficiencies, cancer, and diabetes, and provide an indispensable component to the health care system worldwide, as showcased by mRNA vaccines in the recent pandemic. Despite this success, manufacturing is still based on traditional, outdated batch production technologies, and on process development procedures based on historical experience and empiricism leading to many inefficiencies, like very long values of time-to-market. There is an urgent need to introduce modern integrated, continuous, and fully digitalized production processes, to also cope with the upcoming cell and gene therapies and the emerging personalized medicine. I develop here revolutionary process development and operation methodologies to enable this.
These are based on a Digital Twin, which includes the first continuous, integrated and fully digitalized plant for producing mRNA. The “engine” are innovative hybrid models for each unit of the plant, which are updated on real time through continuous learning techniques. These provide the predictive capabilities needed for monitoring and control, knowledge transfer, scenario analysis and experimental planning.
I will develop a new generation of hybrid models and innovative machine learning algorithms and provide the experimental evaluation and validation of my methodologies. Other high precision continuous processes, like flow-chemistry for sustainable catalytic processes or microfluidics for the controlled synthesis of nanomaterials, will benefit from these results.
I am a recognised pioneer in the scientific foundations of continuous operation in biopharma. This inspired me in developing this disruptive Digital-Twin-based methodology and cope with the associated high risk. With about 110 PhD students advised in my career and now active in Academia and Industry, I know how to inspire a new generation of scientists with the novel science emerging from this project.
Wissenschaftliches Gebiet
- natural sciencesphysical sciencesclassical mechanicsfluid mechanicsmicrofluidics
- medical and health sciencesmedical biotechnologygenetic engineeringgene therapy
- medical and health scienceshealth sciencespublic healthepidemiologypandemics
- medical and health scienceshealth sciencespersonalized medicine
- natural sciencescomputer and information sciencesartificial intelligencemachine learning
Schlüsselbegriffe
Programm/Programme
- HORIZON.1.1 - European Research Council (ERC) Main Programme
Thema/Themen
Finanzierungsplan
HORIZON-ERC - HORIZON ERC GrantsGastgebende Einrichtung
546 36 THESSALONIKI
Griechenland