BioFACTORy

CELLINK is proud to be a partner in BioFACTORy, a Horizon Europe-funded collaborative project bringing together 14 partners across nine European countries to advance the manufacturing of cell- and tissue engineered medicinal products (TEMP) for orocraniofacial regeneration.

Project Short Name:

BioFACTORy

Project Long Name:

Fully automated cell and tissue-engineered bioimplant production for orocraniofacial regeneration

Project number:

101286740

Project Duration

1 September 2026 – 31 August 2030

Project Overview

Advanced regenerative therapies offer significant potential for treating patients with orocraniofacial bone defects caused by cancer, infection, or trauma. However, broader adoption remains challenged by complex, costly, and heavily manual manufacturing processes. Current production of autologous bone marrow-derived MSC therapies can exceed €30,000 per patient, highlighting the need for more scalable and cost-effective approaches.

To address these challenges, BioFACTORy will develop the GMP-conform TEMP production suite, an automated platform designed to support the complete manufacturing lifecycle of MSC-based tissue-engineered medicinal products, from cell expansion and quality control to the final tissue-engineered product. The platform will combine laboratory automation, advanced sensors, digital vision systems, and trustworthy AI tools to enable autonomous decision-making based on real-time process data.

Project Objectives

The BioFACTORy consortium aims to:

  • Develop an automated manufacturing platform for MSC-based tissue-engineered medicinal products.
  • Integrate AI, automation, sensing technologies, and biofabrication workflows to support standardized and scalable production.
  • Address donor-to-donor variability through a Quality-by-Design approach and the development of cell priming strategies to improve consistency and performance.
  • Demonstrate the automated production of combined MSC-scaffold bioimplants and evaluate them in a preclinical bone-defect model.
  • Establish a regulatory roadmap toward GMP-compliant clinical trial applications and future clinical use.

How CELLINK is contributing

As a consortium partner, CELLINK contributes expertise in biofabrication technologies and supports the integration of advanced bioprinting solutions into the GMP-compliant, automated BioFACTORy suite for the development and manufacturing of tissue-engineered models. By working alongside leading European researchers, clinicians, and industry partners, CELLINK is helping advance new approaches for scalable regenerative medicine manufacturing by transitioning from MSC-only therapies to combined ATMPs/TEMPs, where cells are combined with personalized scaffolds.

Consortium

The project is coordinated by University of Bergen and includes Ulm University, Fraunhofer-Gesellschaft, King’s College London, Technical University of Applied Sciences Würzburg-Schweinfurt, Istituto Mario Negri IRCCS, Universidad Complutense de Madrid, University of Barcelona, Silesian University of Technology, CELLINK, Ocean TuniCell, F6S, NovaSign GmbH, and PreSens Precision Sensing GmbH.

Expected Impact

By integrating automation, biofabrication, and trustworthy AI, BioFACTORy seeks to make advanced regenerative therapies more scalable, reproducible, and accessible. The project will also establish a roadmap toward future GMP-compliant manufacturing and clinical implementation.

Disclaimer

Funded by the European Union. Views and opinions expressed are however those of the author(s) only
and do not necessarily reflect those of the European Union or European Health and Digital Executive Agency (HADEA).  Neither
the European Union nor the granting authority can be held responsible for them.