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CORDIS

Continuous Digitalized Processes for Producing Biopharmaceuticals

Project description

Modernising biopharmaceutical production

Biopharmaceuticals are critical in healthcare, something that was clearly highlighted by the pivotal role of mRNA vaccines during the pandemic. However, biopharmaceutical manufacturing still relies on outdated batch production technologies and empirically led process development procedures. Funded by the European Research Council, the CoDiBio project plans to develop a digital twin that encompasses the first-ever continuous, integrated and fully digitalised plant for mRNA production. The plant will employ innovative hybrid models for real-time monitoring and control, knowledge transfer, scenario analysis and experimental planning. Project activities will also benefit other emerging processes such as flow chemistry for sustainable catalytic processes and microfluidics for controlled synthesis of nanomaterials.

Objective

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 Despite this success, manufacturing is still based on traditional, outdated batch production technologies, and on process development procedures based on historical experience and empiricism leading to many inefficiencies, like very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.

Host institution

ARISTOTELIO PANEPISTIMIO THESSALONIKIS
Net EU contribution
€ 2 500 000,00
Address
KEDEA BUILDING, TRITIS SEPTEMVRIOU, ARISTOTLE UNIVERSITY CAMPUS
546 36 THESSALONIKI
Greece

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Region
Βόρεια Ελλάδα Κεντρική Μακεδονία Θεσσαλονίκη
Activity type
Higher or Secondary Education Establishments
Links
Total cost
€ 2 500 000,00

Beneficiaries (1)