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Financement de l’UE (3 617 784 €) : Surveillance et contrôle automatisés en ligne pour améliorer les processus et la prise de décision dans la fabrication de thérapies cellulaires et géniques Hor16/09/2022 Programme de recherche et d'innovation de l'UE « Horizon »
Vue d’ensemble
Texte
Surveillance et contrôle automatisés en ligne pour améliorer les processus et la prise de décision dans la fabrication de thérapies cellulaires et géniques
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.
| LIMULA SA | ? |
| Crowdhelix Ltd. | 383 078 € |
| DA Vinci Labs | 324 938 € |
| Exothera SA | 410 250 € |
| JOBST TECHNOLOGIES GmbH | 905 500 € |
| Stemmatters, Biotecnologia e Mediciina Regenerativa SA | 1 020 644 € |
| Technische Universitaet Wien | 573 375 € |
https://cordis.europa.eu/project/id/101070922
Cette annonce se réfère à une date antérieure et ne reflète pas nécessairement l’état actuel. L’état actuel est présenté à la page suivante : Limula SA, La Tour-de-Peilz, Suisse.
