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Call key data
Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs)
Funding Program
Horizon Europe: Cluster 1 - Health
Call number
HORIZON-HLTH-2025-01-IND-01
deadlines
Opening
22.05.2025
Deadline
16.09.2025 17:00
Funding rate
70%
Call budget
€ 40,000,000.00
Estimated EU contribution per project
between € 6,000,000.00 and € 8,000,000.00
Link to the call
Link to the submission
Call content
short description
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”.
Call objectives
New pioneering treatments called Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies, are at the cutting edge of medicines discovery. Owing to their precise nature, ATMPs embody personalised medicine and reflect a shift in medicine towards potentially one-time curative therapies instead of chronic therapies that mainly cure the symptoms but not the underlying cause of diseases.
ATMPs have undergone important technological advancements that are improving their efficacy, precision, scalability, and safety. Additionally, the disease focus of ATMPs is likely to shift further from rare diseases to more common conditions with larger patient populations. However, the development and manufacturing of ATMPs still faces important challenges, such as long development times, expensive manufacturing processes and a fragmented and dispersed biomanufacturing landscape.
The topic focuses on addressing the challenges of ATMP manufacturing, the need for highly specialised equipment and facilities, including in-process quality control and validation tests, scaling up and batch-to-batch reproducibility, whilst maintaining the efficacy of an ATMP product during the manufacturing process and/or the transition from centralised to decentralised manufacturing.
This topic aims to optimise the ATMP production where the general manufacturing process for a given medicinal product has already been established but has not been sufficiently optimised for its scale-up. Collaboration is crucial to refine the manufacturing of ATMPs, emphasising advancements in processes - including leveraging the potential of digital tools and advanced sensors -, fostering standardisation and enhancing quality controls for more efficient production and deployment of these innovative therapies, ideally covering the entire manufacturing lifecycle.
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Expected effects and impacts
The proposals should address all the following activities for only one chosen category of ATMP as defined by Regulation 1394/2007 per proposal:
- Design an improved manufacturing process for ATMPs by:
- Exploring the potential of platform technologies in manufacturing, quality control, non-clinical or clinical testing;
- Integrating either computational modelling, automation, robotics or digital/Artificial Intelligence solutions with meaningful and measurable impact;
- Verify the improved performance of the developed process, in comparison to established ones.
- Demonstrate a reduction in the timeframe and costs of manufacturing while maintaining product quality and standardisation.
- Demonstrate the translatability, scalability, and robustness of the process suitable for the flexible manufacturing (centralised or decentralised) and deployment of ATMPs by important stakeholders in a patient-centric manner, including the medical community and hospitals.
- Assess the process and methods developed for their regulatory validity and utility (for example standardised assays including for potency), taking into consideration the potential regulatory impact of the results and, as relevant, develop a regulatory strategy for generating appropriate evidence as well as engaging with regulators in a timely manner.
- Promote green and sustainable industrial production and minimise environmental impact.
Participation of small and medium-sized enterprises (SMEs) is strongly encouraged and proposals should include a commitment for first deployment in the EU.
Where relevant, proposals are warmly invited to liaise with the Coordination and Support Action (CSA) project JOIN4ATMP, in view of creating complementarities and potential synergies.
The Joint Research Centre (JRC) may participate as a member of the consortium selected for funding. Proposals should consider the involvement of the European Commission's JRC regarding its experience in this field and with respect to the value it could bring in providing an effective interface between research activities and pre-normative science as well as strategies and frameworks that address regulatory requirements. In that respect, the JRC will consider collaborating with any successful proposal and this collaboration, when relevant, should be established after the proposal’s approval.
Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.
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Expected results
Proposals under this topic should aim to deliver results that are directed, tailored towards and contributing to most of the following expected outcomes:
- Academic and industrial developers advance processes that support the timely and robust development of Advanced Therapy Medicinal Products (ATMPs);
- Manufacturers integrate improved technologies/processes (including Artificial Intelligence solutions), analytic tools, methods including non-clinical methods and assays for more flexible manufacturing of ATMPs;
- Healthcare providers, researchers and patients get faster access to ATMPs with demonstrated health benefits for unmet medical needs;
- Companies in the EU and Associated countries get a better market position in the field of ATMP manufacturing and improve their knowledge on how to advance process improvements;
- The EU and Associated countries lay the foundations for academic centres of excellence in ATMPs.
Eligibility Criteria
Regions / countries for funding
Moldova (Moldova), Albania (Shqipëria), Armenia (Հայաստան), Bosnia and Herzegovina (Bosna i Hercegovina / Босна и Херцеговина), Canada, Faeroes (Føroyar / Færøerne), Georgia (საქართველო), Iceland (Ísland), Israel (ישראל / إِسْرَائِيل), Kosovo (Kosova/Kosovë / Косово), Montenegro (Црна Гора), New Zealand (Aotearoa), North Macedonia (Северна Македонија), Norway (Norge), Serbia (Srbija/Сpбија), Tunisia (تونس /Tūnis), Türkiye, Ukraine (Україна), United Kingdom
eligible entities
EU Body, Education and training institution, Non-Profit Organisation (NPO) / Non-Governmental Organisation (NGO), Other, Private institution, incl. private company (private for profit), Public Body (national, regional and local; incl. EGTCs), Research Institution incl. University, Small and medium-sized enterprise (SME)
Mandatory partnership
Yes
Project Partnership
To be eligible for funding, applicants must be established in one of the following countries:
- the Member States of the European Union, including their outermost regions
- the Overseas Countries and Territories (OCTs) linked to the Member States
- countries associated to Horizon Europe - see list of particpating countries
Only legal entities forming a consortium are eligible to participate in actions provided that the consortium includes, as beneficiaries, three legal entities independent from each other and each established in a different country as follows:
- at least one independent legal entity established in a Member State; and
- at least two other independent legal entities, each established in different Member States or Associated Countries.
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.
Any legal entity, regardless of its place of establishment, including legal entities from non-associated third countries or international organisations (including international European research organisations) is eligible to participate (whether it is eligible for funding or not), provided that the conditions laid down in the Horizon Europe Regulation have been met, along with any other conditions laid down in the specific call topic.
A ‘legal entity’ means any natural or legal person created and recognised as such under national law, EU law or international law, which has legal personality and which may, acting in its own name, exercise rights and be subject to obligations, or an entity without legal personality.
other eligibility criteria
Specific cases:
- Affiliated entities (i.e. entities with a legal or capital link to a beneficiary which participate in the action with similar rights and obligations to the beneficiaries, but which do not sign the grant agreement and therefore do not become beneficiaries themselves) are allowed, if they are eligible for participation and funding.
- Associated partners (i.e. entities which participate in the action without signing the grant agreement, and without the right to charge costs or claim contributions) are allowed, subject to any conditions regarding associated partners set out in the specific call conditions.
- Entities which do not have legal personality under their national law may exceptionally participate, provided that their representatives have the capacity to undertake legal obligations on their behalf, and offer guarantees to protect the EU’s financial interests equivalent to those offered by legal persons.
- Legal entities created under EU law (EU bodies) including decentralised agencies may be part of the consortium, unless provided for otherwise in their basic act.
- International European research organisations are eligible to receive funding. International organisations with headquarters in a Member State or Associated Country are eligible to receive funding for ‘Training and mobility’ actions or when provided for in the specific call/topic conditions. Other international organisations are not eligible to receive funding, unless provided for in the specific call/topic conditions, or if their participation is considered essential for implementing the action by the granting authority.
- Joint Research Centre (JRC)— Where provided for in the specific call conditions, applicants may include in their proposals the possible contribution of the JRC but the JRC will not participate in the preparation and submission of the proposal. Applicants will indicate the contribution that the JRC could bring to the project based on the scope of the topic text. After the evaluation process, the JRC and the consortium selected for funding may come to an agreement on the specific terms of the participation of the JRC. If an agreement is found, the JRC may accede to the grant agreement as beneficiary requesting zero funding or participate as an associated partner, and would accede to the consortium as a member.
- Associations and interest groupings — Entities composed of members (e.g. European research infrastructure consortia (ERICs)) may participate as ‘sole beneficiaries’ or ‘beneficiaries without legal personality’. However, if the action is in practice implemented by the individual members, those members should also participate (either as beneficiaries or as affiliated entities, otherwise their costs will NOT be eligible.
- EU restrictive measures — Entities subject to EU restrictive measures under Article 29 of the Treaty on the European Union (TEU) and Article 215 of the Treaty on the Functioning of the EU (TFEU) as well as Article 75 TFEU, are not eligible to participate in any capacity, including as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any).
- Legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine — Given the illegal invasion of Ukraine by Russia and the involvement of Belarus, there is currently no appropriate context allowing the implementation of the actions foreseen in this programme with legal entities established in Russia, Belarus, or in non-government controlled territories of Ukraine. Therefore, even where such entities are not subject to EU restrictive measures, such legal entities are not eligible to participate in any capacity. This includes participation as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties (if any). Exceptions may be granted on a case-by-case basis for justified reasons.
With specific regard to measures addressed to Russia, following the adoption of the Council Regulation (EU) 2024/1745 of 24 June 2024 (amending Council Regulation (EU) No 833/2014 of 31 July 2014) concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine, legal entities established outside Russia but whose proprietary rights are directly or indirectly owned for more than 50% by a legal person, entity or body established in Russia are also not eligible to participate in any capacity. - Measures for the protection of the Union budget against breaches of the principles of the rule of law in Hungary — Following the Council Implementing Decision (EU) 2022/2506, as of 16 December 2022, no legal commitments can be entered into with Hungarian public interest trusts established under the Hungarian Act IX of 2021 or any entity they maintain. Affected entities may continue to apply to calls for proposals and can participate without receiving EU funding, as associated partners, if allowed by the call conditions. However, as long as the Council measures are not lifted, such entities are not eligible to participate in any funded role (beneficiaries, affiliated entities, subcontractors, recipients of financial support to third parties, etc.).In case of multi-beneficiary grant calls, applicants will be invited to remove or replace that entity in any funded role and/or to change its status into associated partner. Tasks and budget may be redistributed accordingly.
Additional information
Topics
Relevance for EU Macro-Region
EUSAIR - EU Strategy for the Adriatic and Ionian Region, EUSALP - EU Strategy for the Alpine Space, EUSBSR - EU Strategy for the Baltic Sea Region, EUSDR - EU Strategy for the Danube Region
UN Sustainable Development Goals (UN-SDGs)
Additional Information
Applications must be submitted electronically via the Funders & Tenders Portal electronic submission system (accessible via the topic page in the Search Funding & Tenders section). Paper submissions are NOT possible.
Applications must be submitted using the forms provided inside the electronic submission system (not the templates available on the topic page, which are only for information). The structure and presentation must correspond to the instructions given in the forms.
Applications must be complete and contain all parts and mandatory annexes and supporting documents.
The application form will have two parts:
- Part A (to be filled in directly online) contains administrative information about the applicant organisations (future coordinator and beneficiaries and affiliated entities), the summarised budget for the proposal and call-specific questions;
- Part B (to be downloaded from the Portal submission system, completed and then assembled and re-uploaded as a PDF in the system) contains the technical description of the project.
Annexes and supporting documents will be directly available in the submission system and must be uploaded as PDF files (or other formats allowed by the system).
The limit for a full application (Part B) is 50 pages.
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025). It is mandatory to submit a detailed budget table using the template available in the Submission system.
Call documents
Horizon Europe Work Programme 2025 Cluster 1 - HealthHorizon Europe Work Programme 2025 Cluster 1 - Health(1200kB)
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