Objetivo
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.
Ámbito científico
- engineering and technologyelectrical engineering, electronic engineering, information engineeringelectronic engineeringsensorsbiosensors
- engineering and technologymechanical engineeringmanufacturing engineering
- engineering and technologyenvironmental biotechnologybioremediationbioreactors
- medical and health sciencesmedical biotechnologygenetic engineeringgene therapy
- medical and health sciencesmedical biotechnologycells technologies
Palabras clave
Programa(s)
- HORIZON.3.1 - The European Innovation Council (EIC) Main Programme
Tema(s)
Convocatoria de propuestas
HORIZON-EIC-2021-PATHFINDERCHALLENGES-01
Consulte otros proyectos de esta convocatoriaRégimen de financiación
HORIZON-EIC - HORIZON EIC GrantsCoordinador
37380 Reugny
Francia
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.