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Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs)

European Commission

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, 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[1] in ATMPs.

Scope:

New pioneering treatments called Advanced Therapy Medicinal Products (ATMPs)[2], 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.

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[3], 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[4] should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.

AI Based Application Success Predictor

🧪 1. Scientific Excellence Is Paramount

For ERC grants, excellence is the sole selection criterion—evaluations focus exclusively on the quality of the research and track record .

Peer-reviewers adhere strictly to predefined criteria (e.g., Horizon ITN evaluations), and weaknesses—rather than strengths—often decide the outcome .

🌍 2. Strategic Alignment with EU Priorities

Horizon Europe emphasizes Green & Digital Transitions and resilience, with specific budget steering across biodiversity, climate, digital, and societal missions .

Proposals that clearly align with these strategic orientations and EU missions are significantly more competitive.

🤝 3. Strong, Diverse European Consortia

Horizon projects demand well-balanced consortia across Europe—geographically and disciplinarily diverse, including academia, industry, SMEs, NGOs 

Effective leadership, communication, trust, and active collaboration are key success factors

🧴 4. Proven Research Infrastructure & Track Record

A strong publication record—especially in high-impact venues—and prior grant awards bolster chances .

ERC starting, consolidator, or advanced grants require exceptional citation records, strong proposals, and investigator track records .

📈 5. Robust Project Management

For large collaborative grants, project coordination, administration, and communication are just as crucial as scientific content .

Demonstrating realistic budget planning (100% direct costs + 25% indirect costs), administrative frameworks, and governance structures strengthens proposals .

💼 6. Fostering Mobility & Career Growth

Marie Skłodowska-Curie fellowships emphasize researcher mobility, interdisciplinary training, and developing future talent.

🧷 7. Geographical & Gender Equity

Northern and certain Eastern European institutions currently have higher success rates (≈22% vs below 18% in Southern Europe) .

ERC gender data: male and female applicants have similar success rates, though male applicants apply more frequently .

📌 Key Takeaways

Factor	Why It Matters
Excellence-first	Superior science and investigator record are non-negotiable.
Strategic fit	Alignment with EU green, digital, and mission goals is essential.
Consortium quality	Geographic, sectoral, and expertise balance enhances impact.
Management capacity	Good PM builds confidence in successful delivery.
Experience track record	Publications, previous funding, and citations build credibility.
Mobility & careers	MSCA focuses on researcher development and interdisciplinary collaboration.

🧭 Applicant Tips

Master criteria & avoid weaknesses: Make sure your proposal addresses common reviewer pitfalls—methodology, innovation, budget clarity.

Map to EU priorities: Explicitly connect your objectives to Horizon Europe’s strategic plan (2025–2027).

Build strong consortia early: Prioritize complementary expertise, geography, gender balance, and partner roles.

Show robust project management: Include a Work Package structure, governance plans, and clear communication strategies.

Leverage your track record: Highlight high-impact papers, leadership in projects, and previous awards.

Consider MSCA opportunities: Use them for mobility grants or integrating training into your project.

✅ In Summary

To maximize success with European Commission grants—especially ERC or Horizon Europe—focus relentlessly on scientific excellence, strategic EU alignment, consortium strength, and solid project planning. Combine these with a strong publication record and researcher development elements, and aim to close off any potential reviewer concerns.

Eligibility Requirements

General conditions

1. Admissibility Conditions, Proposal page limit and layout

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 available in the Submission System.

2. Eligible Countries

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.

3. Other Eligible Conditions

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.

The Joint Research Centre (JRC) may participate as member of the consortium selected for 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).

Other Eligible Conditions are described in Annex B of the Work Programme General Annexes.

4. Financial and operational capacity and exclusion

Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.

5a. Evaluation and award: Award criteria, scoring and thresholds

Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.

5b. Evaluation and award: Submission and evaluation processes

The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.

Evaluation and award: 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 agreement

Evaluation and award: Indicative 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 grants

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) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].

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.

Sponsor Details

Sponsor Institute/Organizations: European Commission

Sponsor Type: Corporate/Non-Profit

Address: Rue de la Loi 200, 1049 Brussels, Belgium

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