Development of cell-free protein synthesis platforms for discovery and/or production of biologicals
Overview
The total budget allocated for this opportunity is €24.5 million, with approximately four grants expected to be awarded, each ranging from €6 million to €8 million. The funding is provided through a Model Grant Agreement based on eligible costs declared by beneficiaries.
Eligible applicants include a broad range of entities such as research institutions, universities, biotech companies, pharmaceutical enterprises, healthcare providers, small and medium-sized enterprises (SMEs), and startups. Notably, legal entities established in the United States of America are also eligible to apply.
The call seeks proposals that address specific bottlenecks within current CFPS deployment, leverage synthetic biology techniques for designing biomolecules, and develop GMP-compliant platforms to produce clinical-grade materials suitable for testing in clinical trials. The focus areas include proteins like antibody fragments and enzymes, emphasizing the need for scalability and flexibility in production systems.
The application process is a straightforward single-stage submission, eliminating preliminary screenings. Proposals will be evaluated against three main criteria: Excellence, Impact, and Implementation, requiring a minimum score per criterion and a cumulative threshold for success.
The opportunity encourages collaboration among consortia, highlighting the importance of diverse expertise in cell-free protein synthesis and related fields. The expected outcomes aim to enhance biopharmaceutical manufacturing, promote innovative health technologies, and improve patient access to affordable pharmaceuticals.
Overall, this call aims to promote advancements in CFPS technology, enabling the EU to maintain competitiveness in biopharmaceutical production while facilitating decentralized manufacturing and personalized medicine approaches.
Detail
The expected outcome of this topic is to support activities that enable or contribute to the impacts of maintaining an innovative, sustainable, and competitive EU health industry. Proposals should deliver results directed at biopharmaceutical industries gaining access to streamlined development and production processes for peptide- or protein-based biologicals, health systems benefiting from enhanced or decentralised production systems for innovative health technologies involving peptides or proteins, and citizens/patients benefiting from better access, availability, and affordability of pharmaceuticals based on biologicals.
The scope of the topic focuses on Cell-Free Protein Synthesis (CFPS) as a viable means for drug development and production. CFPS systems can be based on prokaryotic or eukaryotic cell lysates (including mammalian) or fully synthetic systems. Mammalian cell-based systems are of particular interest for proteins requiring post-translational modification, such as antibody fragments, antigens, virus-like particles, cytokines, enzymes, antimicrobial peptides, and proteins containing non-natural amino acids. CFPS benefits include ease of handling, scalability, on-demand production, rapid product switching, simplified purification, facilitated standardisation and quality control, less energy resources, smaller manufacturing footprint, and the ability to produce proteins toxic to cells. CFPS is also seen as an enabling technology for personalised medicines and decentralised manufacturing, with increased interest due to advances in synthetic biology and Machine-Learning/Artificial Intelligence (ML/AI). Generative deep learning and AI have high potential in the de-novo design of biomolecules, and CFPS can increase the throughput in screening these biomolecules. The application of synthetic biology, generative AI, and cell-free biosynthesis can open new avenues for therapeutics and vaccines against infectious and non-communicable diseases.
Proposals should address at least two of the following elements:
Address the bottlenecks that currently hamper the large-scale deployment of CFPS, i.e. the lack of a quality-by-design approach, the need to fully characterise the underlying cell lysates and their critical quality attributes and the need for better understanding of the correlations between specific cell lysate properties and CFPS process parameters, specific product quality attributes (such as protein folding), and CFPS platform performance.
Use synthetic biology techniques for the design of de-novo biomolecules with specific desired properties (antimicrobial, immunogenic, angiogenic, etc.) and develop suitable cell-free systems for the high-throughput screening of the designed biomolecules.
Develop novel or optimise existing CFPS platforms for the production of the targeted biomolecule to a Good Manufacturing Practices (GMP) conform process, producing clinical-grade material that can be tested in clinical trials.
Demonstrating the superiority of the developed CFPS platform compared to the current state-of-the-art production system for a specific therapeutic peptide or protein is an asset. Participation of start-ups, micro, small, and medium-sized enterprises (SMEs) is encouraged. Applicants including clinical studies should provide details in the dedicated annex.
The admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes. Proposal page limits and layout are described in Part B of the Application Form in the Submission System. Eligible countries are described in Annex B of the Work Programme General Annexes. Legal entities from the United States of America are eligible to receive Union funding. Projects using satellite-based earth observation, positioning, navigation, and/or related timing data and services must use Copernicus and/or Galileo/EGNOS. 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), with a cumulative threshold of 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. The indicative timeline for evaluation and grant agreement is described in Annex F of the Work Programme General Annexes. The granting authority may object to a transfer of ownership or exclusive licensing of results up to 4 years after the action's end, as set out in 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.
Application and evaluation form templates include a standard application form (HE RIA, IA) and a standard evaluation form (HE RIA, IA), both available in the Submission System. Guidance documents include the HE Programme Guide and the Model Grant Agreement (MGA). Call-specific instructions and information on clinical studies are also provided. Additional documents include the HE Main Work Programme 2026-2027 (General Introduction, Health, and General Annexes), the HE Programme Guide, the HE Framework Programme 2021/695, the HE Specific Programme Decision 2021/764, the EU Financial Regulation 2024/2509, the Decision authorising the use of lump sum contributions under the Horizon Europe Programme, Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment, the EU Grants AGA Annotated Model Grant Agreement, the Funding & Tenders Portal Online Manual, the Funding & Tenders Portal Terms and Conditions, and the Funding & Tenders Portal Privacy Statement.
The budget overview lists several topics with their respective budgets, stages, opening dates, deadlines, contributions, and indicative number of grants. The HORIZON-HLTH-2027-01-IND-01 topic has a budget of 24,500,000 EUR, is a single-stage action, opens on 2027-02-10, closes on 2027-04-13, has contributions ranging from 6,000,000 to 8,000,000 EUR, and an indicative number of 4 grants.
Partner search announcements are available for those seeking partners to collaborate on this topic. LEARs, Account Administrators, and self-registrants can publish partner requests. The submission system is planned to open on the date stated on the topic header. There are currently no topic Q&As.
Support resources include the Online Manual, Horizon Europe Programme Guide, Funding & Tenders Portal FAQ, Research Enquiry Service, National Contact Points (NCPs), Enterprise Europe Network, IT Helpdesk, European IPR Helpdesk, CEN-CENELEC Research Helpdesk, ETSI Research Helpdesk, the European Charter for Researchers, and a Partner Search function.
In summary, this Horizon Europe call focuses on advancing cell-free protein synthesis (CFPS) for the discovery and production of biological therapeutics. It encourages projects that address current limitations in CFPS technology, utilise synthetic biology and AI for biomolecule design, and develop GMP-compliant CFPS platforms. The call aims to improve the efficiency, accessibility, and affordability of protein-based pharmaceuticals, with a particular emphasis on the participation of SMEs and the potential for clinical studies. The total budget for the HORIZON-HLTH-2027-01-IND-01 topic is 24.5 million EUR, with individual grants expected to range from 6 to 8 million EUR. The call is a single-stage action, opening on February 10, 2027, and closing on April 13, 2027.
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Breakdown
Funding Type: The funding type is primarily a grant, specifically a HORIZON Research and Innovation Action (HORIZON-RIA). There is also a HORIZON Pre-commercial Procurement (HORIZON-PCP) action mentioned in the budget overview.
Consortium Requirement: The opportunity appears to allow for both single applicants and consortia. The text encourages participation of SMEs, which often implies a consortium approach, but does not explicitly exclude single applicants.
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. 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.
Target Sector: The primary target sector is health, specifically focusing on biopharmaceutical industries, health systems, and pharmaceuticals based on biologicals. The specific area of focus is on Cell-Free Protein Synthesis (CFPS) platforms, synthetic biology, machine learning/artificial intelligence, and the design, discovery, and manufacture of therapeutics and vaccines.
Mentioned Countries: United States of America.
Project Stage: The project stage spans from development to clinical trials. The call encourages projects that address bottlenecks in large-scale CFPS deployment, design de-novo biomolecules, and develop GMP-conform processes for clinical-grade material.
Funding Amount: The funding amounts vary depending on the specific topic within the call, ranging from €3,000,000 to €11,000,000. The budget overview provides a detailed breakdown for each topic.
HORIZON-HLTH-2027-01-CARE-02: €8,000,000 to €10,000,000
HORIZON-HLTH-2027-01-DISEASE-05: €9,000,000 to €11,000,000
HORIZON-HLTH-2027-01-DISEASE-06: €9,000,000 to €10,000,000
HORIZON-HLTH-2027-01-DISEASE-07: €9,000,000 to €10,000,000
HORIZON-HLTH-2027-01-DISEASE-08: €8,000,000 to €10,000,000
HORIZON-HLTH-2027-01-DISEASE-10: €3,000,000 to €4,000,000
HORIZON-HLTH-2027-01-ENVHLTH-02: €10,000,000 to €11,000,000
HORIZON-HLTH-2027-01-ENVHLTH-MISSCLIMA-03: €4,000,000 to €5,000,000
HORIZON-HLTH-2027-01-IND-01: €6,000,000 to €8,000,000
HORIZON-HLTH-2027-01-STAYHLTH-01: €6,000,000 to €8,000,000
Application Type: The application type is an open call, with a single-stage submission process.
Nature of Support: Beneficiaries will receive money in the form of a grant to support their research and innovation activities.
Application Stages: The application process is a single-stage process.
Success Rates: The success rates are not explicitly mentioned in the provided text.
Co-funding Requirement: The text does not explicitly mention a co-funding requirement.
Summary:
This Horizon Europe call focuses on advancing Cell-Free Protein Synthesis (CFPS) platforms for the discovery and production of biologicals, aiming to support the EU health industry's innovation, sustainability, and competitiveness. The call, HORIZON-HLTH-2027-01-IND-01, invites proposals that address bottlenecks in CFPS deployment, utilize synthetic biology and AI for biomolecule design, and develop GMP-conform CFPS platforms for clinical-grade material. The goal is to streamline biopharmaceutical development, enhance health systems with innovative protein-based technologies, and improve patient access to affordable pharmaceuticals. Eligible applicants include start-ups, SMEs, and entities from EU and associated countries, as well as legal entities established in the United States of America. The funding is provided as a grant, with a single-stage application process and a budget ranging from €6,000,000 to €8,000,000 per project. The call encourages projects that span from development to clinical trials, contributing to therapeutics and vaccines for infectious and non-communicable diseases. The application deadline is April 13, 2027.
Short Summary
Impact Support biopharmaceutical industries with streamlined development and production processes for peptide/protein biologicals, enhancing health systems and improving patient access to affordable pharmaceuticals. | Impact | Support biopharmaceutical industries with streamlined development and production processes for peptide/protein biologicals, enhancing health systems and improving patient access to affordable pharmaceuticals. |
Applicant Research institutions, universities, biotech companies, pharmaceutical enterprises, hospitals, healthcare providers, SMEs, start-ups, and large enterprises engaged in pharmaceutical or biotechnology research and development. | Applicant | Research institutions, universities, biotech companies, pharmaceutical enterprises, hospitals, healthcare providers, SMEs, start-ups, and large enterprises engaged in pharmaceutical or biotechnology research and development. |
Developments Development of cell-free protein synthesis platforms for drug development and production, focusing on proteins including antibody fragments, antigens, virus-like particles, cytokines, enzymes, and antimicrobial peptides. | Developments | Development of cell-free protein synthesis platforms for drug development and production, focusing on proteins including antibody fragments, antigens, virus-like particles, cytokines, enzymes, and antimicrobial peptides. |
Applicant Type Broad range of research and innovation entities, including SMEs and start-ups, with explicit eligibility for legal entities from the United States of America. | Applicant Type | Broad range of research and innovation entities, including SMEs and start-ups, with explicit eligibility for legal entities from the United States of America. |
Consortium Consortium arrangements are required; single applicants cannot apply independently. | Consortium | Consortium arrangements are required; single applicants cannot apply independently. |
Funding Amount €6,000,000 to €8,000,000 per project, with a total budget of €24.5 million for the call. | Funding Amount | €6,000,000 to €8,000,000 per project, with a total budget of €24.5 million for the call. |
Countries EU member states, associated countries, and the United States of America are explicitly eligible for funding. | Countries | EU member states, associated countries, and the United States of America are explicitly eligible for funding. |
Industry Biotech/medtech, pharmaceutical development, and healthcare innovation. | Industry | Biotech/medtech, pharmaceutical development, and healthcare innovation. |
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