Deliverables
WP 1 - Clinical needs definition, GMP and regulatory conformity
1.1 Definition of the clinical specification
1.2 Regulatory consultancy for the suite commercialization
1.3 Documentation and adaptation to GMP
1.4 Definition and set-up of the quality controls
1.5 GxP Shipment validation of the IMP from production sites to hospitals
WP 2 - Optimization of the photoresins formulation
2.1 Establish bone and cartilage photoresins
2.2 Characterize the photoresins physical and biological properties
2.3 Scale the resins manufacturing to GMP
WP 3 - Cell processing and cell-based tissue formation
3.1 Establish protocols for cell mixing
3.2 Evaluate resin compositions for cell migration and tissue formation
3.3 Assess materials to form a functional OC unit
3.4 Assess sex-based differences in matrix formation and stimulating capacity
3.5 Establishment of OCT to assess the quality of the bioprinted construct in vitro
WP 4 - Design and assembly of the EndoFLight printer
4.1 Conversion of FLight printer to EndoFLight setting
4.2 Development of modules for extrusion and jetting
4.3 Development of the EndoFLight software
4.4 Validation of EndoFLight bioprinting process
WP 5 - In silicone models
5.1 Develop models to simulate the EndoFLight bioprinting process
5.2 Establish FEM framework for modelling the FLight architectures
5.3 Establish fluid dynamic experiments of nutrient movement and depletion during tissue formation and comparison with FEM models
5.4 Provide a predictive framework on how Flight architecture can be optimized to promote tissue formation
WP 6 - In vitro, ex vivo, and in vivo explant validation
6.1 Demonstrate filling and printing in OC explants and ex vivo maturation
6.2 Assess graft lesion repair in vitro and in vivo
6.3 Compare native OC architecture and maturation with printed tissue
6.4 Sample evaluation by OCT
WP 7 - Pre-clinical in vivo validation and testing in phantoms by surgeons
7.1 Usability testing on phantoms in the OR
7.2 Planning and submission of animal license
7.3 In vivo testing of the suite in a large animal model
WP 8 - Exploitation and IPR managemen
8.1 IP management and development of exploitation strategies
8.2 Roadmap towards exploitation, business and uptake strategy
8.3 Incorporation of spinoff Lumios
8.4 Explore other clinical needs which could be fulfilled by the LUMINATE technology
WP 9 - Project communication and dissemination
9.1 Communication and Dissemination Plan
9.2 Communication channels established
9.3 Dissemination and community building
9.4 Policy recommendations
WP 10 - Project coordination and management
10.1 Organization and administration
10.2 Project reporting
10.3 Quality assurance, risk and data management