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Ongoing
BioFACTORy
Fully automated cell and tissue-engineered bioimplant production for orocraniofacial regeneration
FunderEuropean Commission
Funder Contribution €8,120,650.00
Duration01 Sep 2026 - 31 Aug 2030
Funded underHE | HORIZON-IA
Call for proposalHORIZON-HLTH-2025-01
Project code101286740
Identifiers
Project timeline3%
Description
Craniofacial defects caused by cancer resection, infection, or trauma significantly impair patients’ quality of life by affecting facial aesthetics and masticatory function. While autologous bone grafting remains the clinical standard, it requires secondary surgery, leads to donor site morbidity and prolonged hospitalisation. Europe has pioneered MSC (mesenchymal stem/stromal cell)-based regenerative therapies as alternatives, with our consortium leading key Phase I–IIB trials (FP7 REBORNE, H2020 MAXIBONE). Despite this progress, broader clinical adoption is hindered by high treatment costs and challenges in standardising cell manufacturing. For example, current GMP-compliant production of autologous BMSCs exceeds €30,000 per patient. Commercial GMP-compliant bioreactors (e.g., Quantum®) have improved scalability, but costs remain high due to consumables and maintenance. BioFACTORy addresses these limitations by developing GMP-conform automated platform powered by trustworthy AI tools (AI Biologist) to optimise the manufacturing of MSC-based tissue engineered medicinal products (TEMP). The system will improve standardisation and scalability while reducing production cost by optimising all steps from cell isolation and expansion to quality control. The project will also address the batch-to-batch/donor-to-donor inconsistency and resulting therapeutic uncertainty by implementing quality-by-design principles in MSC manufacturing, namely development of critical quality attributes (CQAs) and MSC licensing strategies. In parallel, the consortium will engage with EU regulators to develop regulatory roadmaps, ensuring clinical readiness. With expertises in GMP cell production, cell therapy, AI and lab automation in the consortium, BioFACTORy will lay the groundwork for scalable, cost-effective, and reproducible production of TEMPs, positioning Europe as a leader in personalised regenerative medicine, with a focus on orocraniofacial reconstruction.
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Craniofacial defects caused by cancer resection, infection, or trauma significantly impair patients’ quality of life by affecting facial aesthetics and masticatory function. While autologous bone grafting remains the clinical standard, it requires secondary surgery, leads to donor site morbidity and prolonged hospitalisation. Europe has pioneered MSC (mesenchymal stem/stromal cell)-based regenerative therapies as alternatives, with our consortium leading key Phase I–IIB trials (FP7 REBORNE, H2020 MAXIBONE). Despite this progress, broader clinical adoption is hindered by high treatment costs and challenges in standardising cell manufacturing. For example, current GMP-compliant production of autologous BMSCs exceeds €30,000 per patient. Commercial GMP-compliant bioreactors (e.g., Quantum®) have improved scalability, but costs remain high due to consumables and maintenance. BioFACTORy addresses these limitations by developing GMP-conform automated platform powered by trustworthy AI tools (AI Biologist) to optimise the manufacturing of MSC-based tissue engineered medicinal products (TEMP). The system will improve standardisation and scalability while reducing production cost by optimising all steps from cell isolation and expansion to quality control. The project will also address the batch-to-batch/donor-to-donor inconsistency and resulting therapeutic uncertainty by implementing quality-by-design principles in MSC manufacturing, namely development of critical quality attributes (CQAs) and MSC licensing strategies. In parallel, the consortium will engage with EU regulators to develop regulatory roadmaps, ensuring clinical readiness. With expertises in GMP cell production, cell therapy, AI and lab automation in the consortium, BioFACTORy will lay the groundwork for scalable, cost-effective, and reproducible production of TEMPs, positioning Europe as a leader in personalised regenerative medicine, with a focus on orocraniofacial reconstruction.
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Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. 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Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. Provider Academic Bibliometrics & Assessment Computational Utility Service Expiration Session Name greekSession Description Stores the user session ID for Academic Bibliometrics & Assessment Computational Utility Service. 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