Dezvoltarea platformelor de sinteză a proteinelor fără celule pentru descoperirea și/sau producția de biologice

Orizont Europa

Pe scurt

Această finanțare Horizont Europa susține proiectele de cercetare și inovare care dezvoltă platforme de sinteză a proteinelor fără celule (CFPS) pentru descoperirea și producția de medicamente biologice pe bază de peptide sau proteine. Banile acoperă cercetarea, optimizarea și scalarea acestor platforme, inclusiv aducerea procesului la standarde de fabricație GMP și testarea în studii clinice, cu Granturi între 6 și 8 milioane de euro pe proiect. Pot aplica consorții de organizații din UE și țările asociate, iar participarea start-up-urilor și a întreprinderilor mici și mijlocii este încurajată.

Grant per proiect

6.000.000 la 8.000.000 EUR

Buget total apel

24.500.000 EUR

Se deschide

29.10.2026

Tip de acțiune

HORIZON Research and Innovation Actions

Eligibilitate România

Organizațiile din România pot aplica

Identificator apel

HORIZON-HLTH-2027-01-IND-01

Sursă

Portalul UE pentru finanțări (apeluri tematice)

Expected Outcome:This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable, and competitive EU health industry”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes:Biopharmaceutical industries get access to streamlined development and production processes for peptide- or protein-based biologicals.Health systems benefit from the availability of enhanced or decentralised production systems for innovative health technologies that involve peptides or proteins, and which improve health and care.Citizens and patients will benefit from better access, availability and affordability of pharmaceuticals based on biologicals. Scope:Cell-Free Protein Synthesis (CFPS) has been employed in fundamental biological research for decades, however, interest for the approach as a viable means for drug development and production has only emerged in recent years. The advantages that CFPS provides in terms of efficiency, simplicity, flexibility, cost- and time savings outweigh the hurdles that are still to be overcome for CFPS to become a routine manufacturing system for peptide- or protein-based biologicals.Currently, there are several CFPS systems used that are either based on prokaryotic or eukaryotic cell lysates (including mammalian) or fully synthetic systems consisting of all the molecular machinery necessary to create functional proteins. The choice of a specific lysate is dictated by the target protein and the end-use application. Proteins that require post-translational modification are generally produced using lysates of mammalian cells. Hence systems based on mammalian cells are of particular interest as they combine properties inherent to eukaryotic cells and their ability to produce human-like glycosylated proteins with the advantages of cell-free synthesis. These proteins include antibody fragments, antigens, virus-like particles, cytokines, enzymes, antimicrobial peptides and proteins containing non-natural amino acids. The benefits of CFPS are manifold, from ease of handling and scalability, on-demand launch of production, ability to rapidly switch products, simplified purification to facilitated standardisation and quality control. CFPS needs less energy resources, the manufacturing footprint is less complex and smaller than in cell cultivation and it enables production of proteins that have toxic effects on cells. In addition, CFPS has the potential as an enabling technology for personalised medicines and is amenable to decentralised manufacturing. CFPS has gained even more interest in the recent past owing to advances in synthetic biology and thanks to the rise of Machine-Learning/Artificial Intelligence (ML/AI). The use of generative deep learning and artificial intelligence has high potential in the de-novo design of biomolecules with specific properties of therapeutic and/or preventive nature. CFPS offers here great opportunities to increase the throughput in screening of the de-novo created biomolecules.The application of synthetic biology, potentially also combined with generative AI, and cell-free biosynthesis open up new avenues for the design, discovery and manufacture of therapeutics not only against infectious diseases, but also non-communicable diseases and equally for vaccines.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)[1] conform process, producing clinical-grade material that can be tested in clinical trials. The demonstration of the superiority of the developed CFPS platform as compared to the current state-of-the art production system for a specific therapeutic peptide or protein would be an asset and participation of start-ups, micro, small and medium-sized enterprises (SMEs)[2] is encouraged.Applicants envisaging to include clinical studies[3] should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.[1] https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en[2] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361[3] Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application.

General conditions1. Admissibility Conditions, proposal page limit and layoutAdmissibility 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 available in the Submission System.2. Eligible CountriesEligible 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.3. Other Eligibility ConditionsIn 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).Subject to restrictions for the protection of European communication networks.Other eligibility conditions are described in Annex B of the Work Programme General Annexes.4. Financial and operational capacity and exclusionFinancial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.5a. Evaluation and award: Award criteria, scoring and thresholdsAward criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.5b. Evaluation and award: Submission and evaluation processesThe 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.5c. Evaluation and award: Indicative timeline for evaluation and grant agreementIndicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.6. Legal and financial set-up of the grantsThe 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 Specific conditions are described in the specific topic of the Work Programme. Application and evaluation forms and additional documents: Application and evaluation form templatesStandard application form (HE RIA, IA) - the application form specific to this call is available in the Submission SystemStandard evaluation form (HE RIA, IA) - will be used with the necessary adaptationsGuidanceHE Programme GuideModel Grant Agreement (MGA)HE MGACall-specific instructions Information on clinical studies (HE)Additional documents HE Main Work Programme 2026-2027-1. General IntroductionHE Main Work Programme 2026-2027-4. HealthHE Main Work Programme 2026-2027-15. General AnnexesHE Programme GuideHE Framework Programme 2021/695HE Specific Programme Decision 2021/764EU Financial Regulation 2024/2509Decision authorising the use of lump sum contributions under the Horizon Europe ProgrammeRules for Legal Entity Validation, LEAR Appointment and Financial Capacity AssessmentEU Grants AGA, Annotated Model Grant AgreementFunding & Tenders Portal Online ManualFunding & Tenders Portal Terms and ConditionsFunding & Tenders Portal Privacy Statement

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