Advancing bio-printing of living cells for regenerative medicine

The Horizon Europe grant opportunity titled "Advancing bio-printing of living cells for regenerative medicine" (HORIZON-HLTH-2027-03-TOOL-02) aims to advance tissue-specific 3D bio-printing technology for regenerative medicine. This call, part of the Cluster 1 Health program, is set to open on June 3, 2027, with a deadline for submissions on September 22, 2027. The total budget for this initiative is €39.3 million, with an expected four grants available, each ranging from €7 million to €10 million.

Eligible applicants include universities, research institutes, public organizations, private companies (especially SMEs), hospitals, and healthcare providers. The call encourages the formation of multidisciplinary consortia that include biomedical engineers, scientists, and clinicians, as well as participation from entities in the United States.

Funding will be provided as grants under the HORIZON Research and Innovation Actions model, specifically through a budget-based Action Grant mechanism. Proposals must focus on developing or enhancing bio-printing technologies, scaling manufacturing to comply with Good Manufacturing Practices, and performing necessary regulatory work to support clinical studies.

The geographic eligibility extends to EU and EEA member states, as well as associated countries and legal entities from the USA. Projects can operate at various stages, including preclinical and clinical development, targeting various health conditions and aiming to address significant medical needs.

The application process will be a single-stage submission, facilitating accessibility for all eligible parties. While co-funding is not explicitly required, it is encouraged to demonstrate commitment and leverage additional resources.

The overall emphasis of this grant opportunity is on overcoming existing challenges in translating bio-printing technologies from laboratory settings to practical clinical applications, particularly for vital internal organs. Successful proposals will demonstrate a clear understanding of regulatory requirements, production processes, and the clinical value of their technologies.

This is a Horizon Europe (HORIZON) Call, specifically Cluster 1 Health (Single stage 2027/2) (HORIZON-HLTH-2027-03). The topic is Advancing bio-printing of living cells for regenerative medicine, specifically HORIZON-HLTH-2027-03-TOOL-02. It is a HORIZON Research and Innovation Action (HORIZON-RIA). The type of Model Grant Agreement (MGA) is HORIZON Action Grant Budget-Based [HORIZON-AG]. The deadline model is single-stage. The planned opening date is 03 June 2027, and the deadline date is 22 September 2027 at 17:00:00 Brussels time.

The expected outcomes of this topic are: Biomedical scientists from academia and industry will gain access to entire bio-printing units designed to regenerate human tissue. Healthcare professionals acquire information on the safe and effective use of equipment enabling advanced therapies with bio-printed human tissue. Healthcare providers dispose of tools enabling them to treat conditions of unmet medical need. Individual patients will benefit from a personalised approach to their respective medical condition thanks to the bio-printed regenerative medicine solution.

The scope of the topic is as follows: Tissue-specific functional 3D bio-printing of living cells has made significant progress as a new approach for transplantation applications in regenerative medicine. There are currently several types of bio-printing technologies under development for the repair of different targeted tissues or organs. To fully unleash the potential of bio-printed cell constructs for regenerative medicine several bottlenecks still need to be overcome. Various studies in pre-clinical models have shown that bio-printed cell constructs or tissues hold great promise for regenerative medicine, by allowing autologous tissue grafts being printed thus avoiding adverse graft-host reactions. However, translation of such approaches into clinical settings (i.e. humans) and their application to internal organs still needs to be investigated and demonstrated. Dependant on the actual target site (i.e. the defect tissue or organ in the human body) different bio-printing approaches may be preferable. For printing complex tissues and especially entire organs an in-vitro approach followed by transplantation is the preferred way. “In-situ” bio-printing, sometimes also referred to as “in-vivo”, or as “intraoperative”, reflects a bioprinting process performed on a live subject in a surgical setting and has in certain instances (e.g. tissue repair) advantages over an in-vitro bio-printing technique followed by transplantation. In-situ bio-printing involves direct patterning of bio-inks onto a patient’s body at the target site, allowing for precise construction of a site-matching tissue-structure within the actual physiological location where regeneration or repair is needed. As such, in-situ bio-printing allows for high adaptability, reduced risk of contamination, improved cell viability, function and host integration. The high cell densities present in the human vital organs underscore the importance of bio-inks which contain less additional biomaterials as matrix. Hence the bio-printing of cell constructs that comprise native tissue-like cell densities may facilitate repair and/or regeneration of defective complex tissues or internal organs. For such approaches meticulous engineering of the bio-printing equipment is necessary, involving sophisticated micro-surgical instrumentation and medical imaging platforms. To achieve the desired function and to mimic the natural cues in native tissues for in-vitro printed bio-constructs, the use of additional stimuli is needed, whereas in-situ approaches normally rely on the body as natural bioreactor providing the necessary extracellular cues. Recently, combinations of in-situ bio-printing with real-time stimuli have been investigated, even for the repair of internal organs. However, there remain bottlenecks that need to be overcome, like the integration with existing imaging modalities and surgical procedures or the long-time stability and functionality of the created bio-constructs.

To address these challenges, researchers should work in multidisciplinary teams with engineers, biomedical scientists, cell biologists and medical doctors. Proposals should be based on the use of human cells and address all the following activities: Develop or improve existing bioprinting equipment that comprises all steps of the bio-printing suite to print bio-constructs with high cell-density for improved vascularisation and faster repair of the defect in the body. Scale-up the chosen bio-printing technology to a Good Manufacturing Practices (GMP) conform/compliant manufacturing process. Perform all necessary regulatory work enabling the conduct of clinical studies and assess the clinical value of the developed bio-printing technology in first in-human studies.

Priority should be given to bio-printing approaches that either target vital internal organs followed by surgical grafting or employ in-situ approaches depositing the cell-laden bioink directly from the printhead or endoscope on the defect target site in the body. Regulatory knowledge of the field is desired and should be documented through contacts with relevant national or international European regulatory authorities. A good understanding of the different steps involved and the inherent risks in each of these steps will be a basis to identify appropriate safety and quality requirements. Requirements from the different established EU frameworks on Substances of Human Origin (SoHO), medical devices and pharmaceuticals including Advanced Therapy Medicinal Products (ATMPs) should be considered for manufacturing/preparation as well as for clinical outcome monitoring. A combination of requirements from different frameworks might be most appropriate to allow for responsible and fast uptake.

Proposals under this topic may address any therapeutic area, i.e. any disease, dysfunction or defect. Sex differences at the cellular level should be taken into consideration. Preclinical stage and clinical development are eligible. The involvement of small and medium-sized enterprises (SMEs) is encouraged. The European Commission's Joint Research Centre (JRC) may contribute to the proposals selected for funding with work on strategic technologies for economic security and innovative industrial ecosystems, particularly activities on innovation in vitro biotechnologies. Applicants should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged.

The admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. The proposal page limits and layout are described in Part B of the Application Form available in the Submission System. Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide. In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding. If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used). The Joint Research Centre (JRC) may participate as member of the consortium selected for funding as a beneficiary with zero funding, or as an associated partner. The JRC will not participate in the preparation and submission of the proposal - see General Annex B. Other eligibility conditions are described in Annex B of the Work Programme General Annexes. Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes. Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes. The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes. The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5. Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

The application and evaluation form templates include the Standard application form (HE RIA, IA), which is available in the Submission System, and the Standard evaluation form (HE RIA, IA), which will be used with the necessary adaptations. Guidance is provided in the HE Programme Guide and the Model Grant Agreement (MGA) HE MGA. Call-specific instructions are available for Information on clinical studies (HE). Additional documents include the HE Main Work Programme 2026-2027 – 1. General Introduction, HE Main Work Programme 2026-2027 – 4. Health, HE Main Work Programme 2026-2027 – 15. General Annexes, HE Programme Guide, HE Framework Programme 2021/695, HE Specific Programme Decision 2021/764, EU Financial Regulation 2024/2509, Decision authorising the use of lump sum contributions under the Horizon Europe Programme, Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment, EU Grants AGA — Annotated Model Grant Agreement, Funding & Tenders Portal Online Manual, Funding & Tenders Portal Terms and Conditions, and Funding & Tenders Portal Privacy Statement.

The budget overview for 2027 includes: HORIZON-HLTH-2027-03-TOOL-02 - HORIZON-RIA HORIZON Research and Innovation Actions with a budget of EUR 39,300,000, a single-stage process, an opening date of 2027-06-03, a deadline of 2027-09-22, contributions ranging from EUR 7,000,000 to EUR 10,000,000, and an indicative number of 4 grants. HORIZON-HLTH-2027-03-TOOL-04 - HORIZON-RIA HORIZON Research and Innovation Actions with a budget of EUR 39,300,000, a single-stage process, an opening date of 2027-06-03, a deadline of 2027-09-22, contributions ranging from EUR 10,000,000 to EUR 12,000,000, and an indicative number of 4 grants. HORIZON-HLTH-2027-03-TOOL-08 - HORIZON-CSA HORIZON Coordination and Support Actions with a budget of EUR 2,900,000, a single-stage process, an opening date of 2027-06-03, a deadline of 2027-09-22, a contribution of around EUR 2,900,000, and an indicative number of 1 grant.

There is one partner search announcement available. LEARs, Account Administrators, or self-registrants can publish partner requests for open and forthcoming topics after logging into the Portal, as well as any user having an active public Person profile. The submission system is planned to be opened on the date stated on the topic header.

Applicants should carefully read all provisions before preparing their application. The Online Manual is a guide on the procedures from proposal submission to managing the grant. The Horizon Europe Programme Guide contains detailed guidance on the structure, budget, and political priorities of Horizon Europe. The Funding & Tenders Portal FAQ provides answers to frequently asked questions on submission of proposals, evaluation, and grant management. The Research Enquiry Service can answer questions about any aspect of European research in general and the EU Research Framework Programmes in particular. National Contact Points (NCPs) offer guidance, practical information, and assistance on participation in Horizon Europe. The Enterprise Europe Network (EEN) can advise businesses, especially SMEs, and provide guidance on EU research funding. The IT Helpdesk can assist with technical aspects of proposal submission, such as forgotten passwords and access rights. The European IPR Helpdesk assists with intellectual property issues. The CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk advise on how to tackle standardisation in project proposals. The European Charter for Researchers and the Code of Conduct for their recruitment outline the roles, responsibilities, and entitlements of researchers, employers, and funders. Partner Search helps find partner organisations for proposals.

In summary, this Horizon Europe call aims to advance bio-printing technologies for regenerative medicine. It seeks to fund projects that develop or improve bio-printing equipment, scale up manufacturing processes to meet GMP standards, and perform necessary regulatory work to enable clinical studies. The call prioritizes approaches targeting vital internal organs and encourages multidisciplinary teams and the involvement of SMEs. The overall goal is to translate bio-printing technologies into clinical settings, providing personalized regenerative medicine solutions for patients with unmet medical needs. The funding is substantial, with multiple grants available for Research and Innovation Actions and Coordination and Support Actions.

Eligible Applicant Types: The eligible applicant types include, but are not limited to, researchers, engineers, biomedical scientists, cell biologists, medical doctors, and small and medium-sized enterprises (SMEs). The call encourages multidisciplinary teams and the involvement of SMEs. Legal entities established in the United States of America are also eligible to receive Union funding.

Funding Type: The funding type is a grant, specifically a HORIZON Research and Innovation Action (HORIZON-RIA) under the Horizon Europe program. The type of Model Grant Agreement (MGA) is a HORIZON Action Grant Budget-Based [HORIZON-AG]. There are also HORIZON Coordination and Support Actions (HORIZON-CSA).

Consortium Requirement: While not explicitly stated, the call encourages multidisciplinary teams, suggesting that a consortium of multiple applicants is preferred. The Joint Research Centre (JRC) may participate as a member of the consortium.

Beneficiary Scope (Geographic Eligibility): Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.

Target Sector: The target sector is health, specifically regenerative medicine, 3D bio-printing of living cells, tissue engineering, and related biotechnologies. The program aims to develop and use new tools, technologies, and digital solutions for a healthy society.

Mentioned Countries: United States of America.

Project Stage: The project stage can be preclinical or clinical development. The call explicitly mentions that preclinical stage and clinical development are eligible.

Funding Amount: For the topic HORIZON-HLTH-2027-03-TOOL-02, the contribution is between EUR 7,000,000 and EUR 10,000,000. For the topic HORIZON-HLTH-2027-03-TOOL-04, the contribution is between EUR 10,000,000 and EUR 12,000,000. For the topic HORIZON-HLTH-2027-03-TOOL-08, the contribution is around EUR 2,900,000.

Application Type: The application type is a single-stage call.

Nature of Support: Beneficiaries will receive money in the form of a grant.

Application Stages: The application process is a single-stage process.

Success Rates: The success rates are not explicitly mentioned. However, the indicative number of grants for HORIZON-HLTH-2027-03-TOOL-02 and HORIZON-HLTH-2027-03-TOOL-04 is 4, and for HORIZON-HLTH-2027-03-TOOL-08 is 1.

Co-funding Requirement: The information does not explicitly state whether co-funding is required.

Summary:

This Horizon Europe call, under the Cluster 1 Health pillar, focuses on "Advancing bio-printing of living cells for regenerative medicine." The call aims to support activities that contribute to the development and use of new tools, technologies, and digital solutions for a healthy society. The primary goal is to advance tissue-specific functional 3D bio-printing of living cells for transplantation and regenerative medicine applications. The call encourages projects that address bottlenecks in bio-printing, such as translating pre-clinical successes into clinical settings, particularly for internal organs.

The scope includes developing or improving existing bio-printing equipment, scaling up bio-printing technology to GMP-compliant manufacturing processes, performing necessary regulatory work for clinical studies, and assessing the clinical value of developed bio-printing technology in first-in-human studies. Priority is given to bio-printing approaches targeting vital internal organs or employing in-situ approaches.

Eligible applicants should form multidisciplinary teams including engineers, biomedical scientists, cell biologists, and medical doctors. The use of human cells is a requirement. Regulatory knowledge and compliance with EU frameworks on Substances of Human Origin (SoHO), medical devices, and Advanced Therapy Medicinal Products (ATMPs) are desired. The call is open to any therapeutic area and encourages the involvement of SMEs. Legal entities established in the United States of America are also eligible to receive Union funding.

The funding is provided through HORIZON Research and Innovation Actions (RIA) and Coordination and Support Actions (CSA), with contributions ranging from EUR 2,900,000 to EUR 12,000,000 depending on the specific topic. The application process is single-stage, with a planned opening date of June 3, 2027, and a deadline of September 22, 2027.