Objective
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.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine surgery
- social sciences sociology industrial relations automation
- medical and health sciences clinical medicine oncology
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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HORIZON.2.1.5 - Tools, Technologies and Digital Solutions for Health and Care, including personalised medicine
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-IA - HORIZON Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-HLTH-2025-01
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
5020 Bergen
Norway
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.