Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs)

The EU grant opportunity HORIZON-HLTH-2025-01-IND-01 focuses on optimizing the manufacturing processes of Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies. The funding falls under the Horizon Europe Programme, specifically within the Health Cluster, and supports activities aimed at maintaining an innovative and competitive EU health industry.

Eligible applicants include small and medium-sized enterprises (SMEs), academic and industrial developers, manufacturers, healthcare providers, and researchers from the EU and associated countries, as well as legal entities from the United States. A consortium approach is required, emphasizing collaboration among various stakeholders.

The funding type is a lump sum grant, categorized under Horizon Innovation Actions, with a total budget of €40 million allocated for this topic. Individual project funding ranges from €6 million to €8 million. Proposals should target challenges in ATMP manufacturing, such as improving scalability, reducing costs, and ensuring quality. The call is open for submissions until September 16, 2025, with a single-stage application process.

The focus is on optimizing established manufacturing processes and addressing issues like in-process quality control and batch reproducibility. Proposals should integrate advanced technologies, including AI and automation, to enhance flexibility in manufacturing. Successful projects should aim to accelerate patient access to therapies and strengthen the EU's market position in ATMP manufacturing.

SME participation is encouraged, and projects should promote sustainable production practices. The application framework requires compliance with various admissibility conditions and evaluation criteria, ensuring projects align with EU regulations. The grant aims to bolster the healthcare sector by facilitating faster access to ATMPs and establishing academic centers of excellence in the field.

Overall, this grant represents a strategic effort to innovate healthcare solutions within the EU, leveraging technology and collaboration to enhance production efficiency and regulatory compliance in the ATMP sector.

This EU grant opportunity, HORIZON-HLTH-2025-01-IND-01, focuses on "Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs)". It falls under the Horizon Europe Programme, specifically Cluster 1 Health, and is a HORIZON Innovation Action (HORIZON-IA) with a HORIZON Lump Sum Grant [HORIZON-AG-LS] funding mechanism. The call is currently open for submission with a single-stage deadline model. The opening date was May 22, 2025, and the deadline for submissions is September 16, 2025, at 17:00:00 Brussels time.

The primary goal of this topic is to support activities that contribute to "Maintaining an innovative, sustainable, and competitive EU health industry". Successful proposals should aim to deliver results that lead to:

1. Advancement of ATMP development processes by academic and industrial developers.
2. Integration of improved technologies and processes, including AI, analytic tools, and non-clinical methods, for more flexible ATMP manufacturing.
3. Faster access to ATMPs with demonstrated health benefits for patients.
4. Improved market position for EU and Associated Countries in ATMP manufacturing.
5. Establishment of academic centers of excellence in ATMPs within the EU and Associated Countries.

The scope of the grant focuses on addressing the challenges in ATMP manufacturing, including specialized equipment, in-process quality control, scaling up, batch reproducibility, and maintaining product efficacy during manufacturing and transition between centralized and decentralized manufacturing. It aims to optimize ATMP production where the general manufacturing process is established but needs further optimization for scale-up. Collaboration is emphasized to refine ATMP manufacturing, advance processes using digital tools and sensors, foster standardization, and enhance quality controls across the entire manufacturing lifecycle.

Proposals must address the following activities for one chosen category of ATMP as defined by Regulation 1394/2007:

1. Design an improved manufacturing process for ATMPs by:
 Exploring platform technologies in manufacturing, quality control, non-clinical or clinical testing.
 Integrating computational modelling, automation, robotics, or digital/AI solutions.
 Verifying the improved performance of the developed process.
2. Demonstrate a reduction in manufacturing timeframe and costs while maintaining product quality and standardization.
3. Demonstrate the translatability, scalability, and robustness of the process for flexible manufacturing and deployment of ATMPs.
4. Assess the regulatory validity and utility of the developed processes and methods, considering the potential regulatory impact and engaging with regulators.
5. Promote green and sustainable industrial production and minimize environmental impact.

SME participation is strongly encouraged, with a commitment for first deployment in the EU. Applicants are encouraged to liaise with the CSA project JOIN4ATMP to create complementarities and synergies. The Joint Research Centre (JRC) may participate as a consortium member. Applicants including clinical studies should provide details in a dedicated annex.

The admissibility conditions are detailed 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. Eligible countries are listed in Annex B of the Work Programme General Annexes. Legal entities from the USA are eligible for Union funding. The JRC can participate as a consortium member. Projects using satellite data must use Copernicus and/or Galileo/EGNOS. Other eligible conditions are in Annex B. Financial and operational capacity and exclusion criteria are in Annex C. Award criteria, scoring, and thresholds are in Annex D. Submission and evaluation processes are in Annex F and the Online Manual. The thresholds for each criterion (Excellence, Impact, Implementation) are 4, with a cumulative threshold of 12. The indicative timeline for evaluation and grant agreement is in Annex F. Eligible costs will be in the form of a lump sum, as defined in the Decision of 7 July 2021. Legal and financial setups are in Annex G. Specific conditions are described in the specific topic of the Work Programme.

Application and evaluation form templates include the standard application form (HE RIA, IA) and the standard evaluation form (HE RIA, IA). Guidance documents include the HE Programme Guide, Lump Sum MGA, call-specific instructions, information on clinical studies, a detailed budget table, and guidance on lump sums. Additional documents include the HE Main Work Programme 2025, HE Framework Programme 2021/695, EU Financial Regulation 2024/2509, and various guidance documents on legal entity validation, financial capacity assessment, and grant agreements.

The budget overview indicates that the total budget for this topic is 40,000,000 EUR for the year 2025. The estimated contribution per grant ranges from 6,000,000 to 8,000,000 EUR, and the indicative number of grants to be awarded is 5.

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In summary, this grant opportunity aims to boost the EU health industry by optimizing the manufacturing of Advanced Therapy Medicinal Products (ATMPs). It encourages projects that improve manufacturing processes using advanced technologies like AI and robotics, reduce costs and time, ensure scalability, and promote green practices. The goal is to make these innovative therapies more accessible to patients and to strengthen the EU's position in the global ATMP market. The funding is provided as a lump sum, and the application process involves a single stage with a deadline in September 2025. Small and medium-sized enterprises (SMEs) are particularly encouraged to participate.

Eligible Applicant Types: The eligible applicant types include small and medium-sized enterprises (SMEs), academic and industrial developers, manufacturers, healthcare providers, researchers, and companies in the EU and Associated countries. The Joint Research Centre (JRC) may also participate as a member of the consortium. Any legal entity established in the United States of America is also eligible to receive Union funding. Centers of excellence, defined as teams with a clear focus on a particular area of research, are also relevant.

Funding Type: The funding type is a grant, specifically a HORIZON Lump Sum Grant, under the HORIZON Innovation Actions (HORIZON-IA) framework.

Consortium Requirement: A consortium is required, as the Joint Research Centre (JRC) may participate as a member of the consortium. Collaboration is crucial to refine the manufacturing of ATMPs.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes the EU and Associated countries. 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. Also, any legal entity established in the United States of America is eligible to receive Union funding.

Target Sector: The target sector is health, specifically focusing on the manufacturing and development of Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapies. This includes areas such as biotechnology, medtech, pharma/healthcare, and innovation in healthcare processes. The program also emphasizes the integration of digital tools and advanced sensors, suggesting a focus on ICT and artificial intelligence within the health sector.

Mentioned Countries: United States of America, EU, Associated countries.

Project Stage: The project stage is primarily focused on optimizing established manufacturing processes for ATMPs that have not been sufficiently optimized for scale-up. This suggests a focus on development, validation, and potentially demonstration or commercialization, rather than basic research or idea generation.

Funding Amount: The funding amount is variable, with contributions ranging from 6,000,000 to 8,000,000 EUR, as indicated in the budget overview for the HORIZON-HLTH-2025-01-IND-01 topic.

Application Type: The application type is an open call, with a single-stage submission process.

Nature of Support: The beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process involves a single stage.

Success Rates: Success rates are not explicitly mentioned, but the indicative number of grants for the HORIZON-HLTH-2025-01-IND-01 topic is 5.

Co-funding Requirement: Co-funding requirements are not explicitly mentioned.

Summary:

This Horizon Europe funding opportunity, HORIZON-HLTH-2025-01-IND-01, aims to optimize the manufacturing of Advanced Therapy Medicinal Products (ATMPs) to maintain an innovative, sustainable, and competitive EU health industry. The grant targets academic and industrial developers, manufacturers, healthcare providers, researchers, and companies in the EU and Associated countries, as well as legal entities from the United States of America. The funding mechanism is a HORIZON Innovation Action (HORIZON-IA) lump sum grant, requiring a consortium approach. Projects should focus on improving ATMP manufacturing processes by integrating advanced technologies like AI, automation, and advanced sensors, while also reducing costs, improving scalability, and ensuring regulatory compliance. The funding ranges from 6,000,000 to 8,000,000 EUR, and the application process involves a single stage with a deadline of September 16, 2025. The goal is to facilitate faster access to ATMPs for patients, strengthen the EU's market position in ATMP manufacturing, and establish academic centers of excellence in the field. The call encourages participation from SMEs and emphasizes the importance of green and sustainable industrial production. Applicants are also encouraged to liaise with the JOIN4ATMP project and consider involving the European Commission's JRC in their proposals.