Objective 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. Fields of science engineering and technologyelectrical engineering, electronic engineering, information engineeringelectronic engineeringsensorsbiosensorsengineering and technologymechanical engineeringmanufacturing engineeringengineering and technologyenvironmental biotechnologybioremediationbioreactorsmedical and health sciencesmedical biotechnologygenetic engineeringgene therapymedical and health sciencesmedical biotechnologycells technologies Programme(s) HORIZON.3.1 - The European Innovation Council (EIC) Main Programme Topic(s) HORIZON-EIC-2021-PATHFINDERCHALLENGES-01-03 - Emerging Technologies in Cell and Gene therapy Call for proposal HORIZON-EIC-2021-PATHFINDERCHALLENGES-01 See other projects for this call Funding Scheme HORIZON-AG - HORIZON Action Grant Budget-Based Coordinator DA VINCI LABS Net EU contribution € 324 937,50 Address La valliere 37380 Reugny France See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Centre — Val de Loire Centre — Val de Loire Indre-et-Loire Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Participants (5) Sort alphabetically Sort by Net EU contribution Expand all Collapse all JOBST TECHNOLOGIES GMBH Germany Net EU contribution € 905 500,00 Address Engesserstrasse 4 b 79108 Freiburg See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Baden-Württemberg Freiburg Freiburg im Breisgau, Stadtkreis Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 STEMMATTERS, BIOTECNOLOGIA E MEDICIINA REGENERATIVA SA Portugal Net EU contribution € 1 020 643,75 Address Parque de ciencia e tecnologia avepark zona industrial da gandra 4805-017 Barco gmr See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Continente Norte Ave Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 TECHNISCHE UNIVERSITAET WIEN Austria Net EU contribution € 573 375,00 Address Karlsplatz 13 1040 Wien See on map Region Ostösterreich Wien Wien Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 EXOTHERA SA Belgium Net EU contribution € 410 250,00 Address Zoning jumet, allee centrale 52 6040 Jumet See on map Region Région wallonne Prov. Hainaut Arr. Charleroi Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 CROWDHELIX LIMITED Ireland Net EU contribution € 383 077,50 Address Trinity house 7 georges quay T12NAX0 Cork See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Ireland Southern South-East Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Partners (1) Sort alphabetically Sort by Net EU contribution Expand all Collapse all LIMULA SA Switzerland Net EU contribution € 0,00 Address Avenue du clos-d aubonne 19 1814 La tour-de-peilz See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Schweiz/Suisse/Svizzera Région lémanique Vaud Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding No data
