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PAT4CGT

Financiado

Automated online monitoring & control to improve processes and decision making i...

Automated online monitoring & control to improve processes and decision making in cell and gene therapy manufacturing Problem: Cell and gene therapies (CGT) represent a breakthrough in the treatment of a wide range of conditions. However, limited global manufacturing capacity owing to a lack of scalability prevents CGT from becoming widely availa... ver más

30/09/2025

DA VINCI LABS

4M€

Presupuesto del proyecto: 4M€

Líder del proyecto

DA VINCI LABS No se ha especificado una descripción o un objeto social para esta compañía.

Ver 7 Participantes

Financiación concedida El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2022-09-12

HORIZON-EIC-2021-PATHFINDERCHALLENGES-01-03: Emerging Technologies in Cell and G... Scope:Cell and gene therapy (CGT) are widely accepted as top biomedical trends for over three years...

I+D

Cerrada hace 3 años

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7 Participantes

DA VINCI LABS

324.94K€ | Lider

TU WIEN

573.38K€ | Participante

JOBST TECHNOLOGIES GMBH

905.50K€ | Participante

CROWDHELIX LIMITED

383.08K€ | Participante

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Duración del proyecto: 36 meses Fecha Inicio: 2022-09-12
Fecha Fin: 2025-09-30

Líder del proyecto

DA VINCI LABS No se ha especificado una descripción o un objeto social para esta compañía.

Presupuesto del proyecto 4M€

Descripción del proyecto Problem: Cell and gene therapies (CGT) represent a breakthrough in the treatment of a wide range of conditions. However, limited global manufacturing capacity owing to a lack of scalability prevents CGT from becoming widely available to patients: therapies are prepared individually at central facilities in a series of complex open manual steps. Variability is high, and a uniform manufacturing process is lacking. Automated, standardized, quality-controlled, and decentralized processes are urgently needed to scale out CGT manufacturing, bring down costs and enable treatment for millions of patients. True automation requires an understanding of what are known as critical process parameters (CPPs). Currently, manufacturing of cell therapies is carried out over several days, with limited access to knowledge of CPPs, often obtained through intrusive sampling methods. Innovation: We aim to enable in-line continuous monitoring of key cell culture parameters during therapy manufacturing. To do this, we will create a self-contained instrument that connects miniaturized biosensor technologies to a novel bioreactor to allow automation of the entire cell therapy manufacturing process in a closed system. The device will accommodate a disposable, single-use sampling unit that will ultimately be adaptable to any bioreactor. Our platform will carry out continuous, automated, and closed monitoring of a set of well-defined CPPs, as indicators of the overall state of the cell culture. We will select and refine our parameters and establish optimal ranges, as predictors of process outcomes and product quality, based on prediction algorithms and digital twin analysis. This will allow continuous process monitoring, while greatly lowering costs and risks associated with manual sampling. Our first application will be in CAR T cell therapy production, but the advantages of automation with continuous monitoring will be further applied to other CGT product that involves culturing of cells.

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