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

Información del proyecto

PAT4CGT

Identificador del acuerdo de subvención: 101070922

DOI

10.3030/101070922

Proyecto cerrado

Fecha de la firma de la CE 12 Septiembre 2022

Fecha de inicio 1 Octubre 2022

Fecha de finalización 30 Septiembre 2025

Financiado con arreglo a

• The European Innovation Council (EIC)

Coste total

€ 3 617 783,75

Aportación de la UE

€ 3 617 783,75

Coordinado por

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)

Período documentado: 2023-10-01 hasta 2025-09-30

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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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