Automated online monitoring & control to improve processes and decision making in cell and gene therapy manufacturing

Projektinformationen

PAT4CGT

ID Finanzhilfevereinbarung: 101070922

DOI

10.3030/101070922

Projekt abgeschlossen

EK-Unterschriftsdatum 12 September 2022

Startdatum 1 Oktober 2022

Enddatum 30 September 2025

Finanziert unter

• The European Innovation Council (EIC)

Gesamtkosten

€ 3 617 783,75

EU-Beitrag

€ 3 617 783,75

Koordiniert durch

DA VINCI LABS
France

Periodic Reporting for period 2 - PAT4CGT (Automated online monitoring & control to improve processes and decision making in cell and gene therapy manufacturing)

Berichtszeitraum: 2023-10-01 bis 2025-09-30

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

Highly personalised advanced therapy medicinal products (ATMP) such as cell & gene therapies (CGT) represent a breakthrough in medicine, with the promise to become one-off cures for a wide range of conditions. However, making CGT products widely available to patients proved challenging so far. Existing CGT manufacturing processes involve multiple manual steps that need to be performed in high grade clean rooms by skilled professionals who have limited tools to monitor progress over time. This leads to two major problems: unpredictable outcome and high cost – a single dose can cost anywhere from €250k-€2m due, in part, to the labor-intensive nature of the process.
PAT4CGT consortium aimed to overcome these obstacles by developing a solution that supports fully automated CGT manufacturing processes. To achieve the objectives of the project, partners have developed a self-contained analytical instrument to enable non-invasive real-time in-line sensing of critical process parameters (CPPs). Coupled with process automation, this solution will monitor the overall status of the cell culture, obliterating the need for manual sampling steps. The consortium has pooled the expertise of partners to define these CPPs and better understand their role, so that optimal conditions can be found, and process parameters adjusted. The collected data was used to build digital twin models and prediction algorithms that allow process control and increase product quality. The resulting tool will help CGT developers identify key relationships between CPPs, as potential predictors of cell quality and therapeutic outcome. Ultimately, the developed device will enable the biopharma industry to scale CGT production and help patients to access these innovative therapies.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

During the PAT4CGT project, partners have successfully implemented the research programme and tasks stipulated in the Grant Agreement. This has allowed the consortium to progress towards the overall goal of increasing reproducibility and quality of CGT products manufacturing. The project advanced from TRL1/TRL 2 to reach TRL4 at the end of September 2025.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

The consortium has identified three aspects that need to be addressed in order to ensure a successful market entry:

1) Quality: Our end-users will require high quality devices and single use consumables to use in a good manufacturing practices (GMP) compliant environment. We perform tests (biocompatibility, verification and validation) to guarantee that our product meets GMP requirements and specifications;
2) Credibility and visibility: Users will adopt our solution if they see an important improvement in performance compared to existing solutions. To get traction, we need to show high quality validation, both internal and external, and to present robust data;
3) Risk averse industry: Cell therapy developers avoid cumulating asset clinical risk and CMC technology risk. They would rather use suboptimal but proven tools for manufacturing. We need to identify and engage with early adopter customers focused on niche applications as they will likely see enabling value in adopting our technology. This is being facilitated through our engagement with the industry at conferences, and by the portfolio activities within the Pathfinder sub-portfolio.

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