European UnionDeadline PassedNon-profit, Private Business, Research Institution, Public Institution, Other
Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs)
Horizon Europe Health Cluster – Maintaining an innovative, sustainable and competitive EU health industry
Funding Amount
€6.0M - €8.0M
Deadline
16/09/2025
Eligible Organization Types
Non-profit, Private Business, Research Institution, Public Institution, Other
Trusted by
What is the Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs) Call?
Grant Description
This call supports collaborative projects to optimise and scale up established manufacturing processes for Advanced Therapy Medicinal Products by integrating platform technologies, digital and artificial intelligence solutions, improving standardisation and quality controls, reducing time and cost, ensuring regulatory compliance and green production, to strengthen the EU health industry and speed patient access to innovative therapies.
Required Results for Successful Funding
Expected Outcomes
Proposals should deliver results contributing to one or more of the following:
• Academic and industrial developers advance processes that support the timely and robust development of ATMPs.
• Manufacturers integrate improved technologies/processes (including AI solutions), analytical tools, non-clinical methods and assays for more flexible manufacturing of ATMPs.
• Healthcare providers, researchers and patients gain faster access to ATMPs with demonstrated health benefits for unmet medical needs.
• Companies in the EU and Associated countries strengthen their market position in ATMP manufacturing and improve knowledge on advancing process improvements.
• The EU and Associated countries lay the foundations for academic centres of excellence in ATMPs, fostering multidisciplinary research teams and shared facilities.
• Academic and industrial developers advance processes that support the timely and robust development of ATMPs.
• Manufacturers integrate improved technologies/processes (including AI solutions), analytical tools, non-clinical methods and assays for more flexible manufacturing of ATMPs.
• Healthcare providers, researchers and patients gain faster access to ATMPs with demonstrated health benefits for unmet medical needs.
• Companies in the EU and Associated countries strengthen their market position in ATMP manufacturing and improve knowledge on advancing process improvements.
• The EU and Associated countries lay the foundations for academic centres of excellence in ATMPs, fostering multidisciplinary research teams and shared facilities.
Funded areas
Scope Requirements
• Focus on exactly one ATMP category as defined by Regulation 1394/2007, where a general manufacturing process exists but requires optimisation for scale-up.
• Address all of the following mandatory activities:
– Improved process design via platform technologies in manufacturing, quality control and testing;
– Integration of digital tools, computational modelling, automation, robotics or AI with demonstrable, measurable impact;
– Comparative verification of process performance against established standards;
– Demonstration of reduced manufacturing timeframe and cost without compromising product quality or standardisation;
– Proof of translatability, scalability and robustness suitable for centralised and/or decentralised production;
– Regulatory assessment of developed methods (e.g., standardised assays), development of a regulatory strategy and timely regulator engagement;
– Promotion of green and sustainable industrial production with minimal environmental footprint.
• Coverage of the full manufacturing lifecycle is strongly encouraged, including fostering standardisation and enhanced in-process quality control.
• Address all of the following mandatory activities:
– Improved process design via platform technologies in manufacturing, quality control and testing;
– Integration of digital tools, computational modelling, automation, robotics or AI with demonstrable, measurable impact;
– Comparative verification of process performance against established standards;
– Demonstration of reduced manufacturing timeframe and cost without compromising product quality or standardisation;
– Proof of translatability, scalability and robustness suitable for centralised and/or decentralised production;
– Regulatory assessment of developed methods (e.g., standardised assays), development of a regulatory strategy and timely regulator engagement;
– Promotion of green and sustainable industrial production with minimal environmental footprint.
• Coverage of the full manufacturing lifecycle is strongly encouraged, including fostering standardisation and enhanced in-process quality control.
Additional Conditions for Applicants
Special Conditions
• Type of Action: Horizon Innovation Actions (HORIZON-IA) under Horizon Europe.
• Funding Model: Horizon Lump Sum Grant (HORIZON-AG-LS), single-stage.
• Submission Deadline: 16 September 2025, 17:00 Brussels time.
• Ineligible Participants: Legal entities established in China; entities assessed as “high-risk suppliers” of mobile network communication equipment (and their affiliates) for topics under communication network protection restrictions.
• SMEs: Participation is strongly encouraged; proposals must include commitment to first deployment in the EU.
• Liaison & Collaboration: Proposals are invited to liaise with the JOIN 4 ATMP CSA project; consider involvement of the EC’s JRC post-approval for regulatory and pre-normative expertise.
• Clinical Studies: Any clinical studies must be detailed in a dedicated annex using the submission template.
• Data & Services: Projects using satellite-based Earth observation, positioning, navigation or timing must use Copernicus and/or Galileo/EGNOS data/services.
• Eligibility & Evaluation: Eligible countries per Work Programme General Annex B; US entities are eligible; financial/operational capacity and exclusions per Annex C; award criteria and thresholds per Annex D (score thresholds: 4 for Excellence, Impact, Implementation; overall pass mark 12).
• Funding Model: Horizon Lump Sum Grant (HORIZON-AG-LS), single-stage.
• Submission Deadline: 16 September 2025, 17:00 Brussels time.
• Ineligible Participants: Legal entities established in China; entities assessed as “high-risk suppliers” of mobile network communication equipment (and their affiliates) for topics under communication network protection restrictions.
• SMEs: Participation is strongly encouraged; proposals must include commitment to first deployment in the EU.
• Liaison & Collaboration: Proposals are invited to liaise with the JOIN 4 ATMP CSA project; consider involvement of the EC’s JRC post-approval for regulatory and pre-normative expertise.
• Clinical Studies: Any clinical studies must be detailed in a dedicated annex using the submission template.
• Data & Services: Projects using satellite-based Earth observation, positioning, navigation or timing must use Copernicus and/or Galileo/EGNOS data/services.
• Eligibility & Evaluation: Eligible countries per Work Programme General Annex B; US entities are eligible; financial/operational capacity and exclusions per Annex C; award criteria and thresholds per Annex D (score thresholds: 4 for Excellence, Impact, Implementation; overall pass mark 12).
Important dates
Open from: 22/05/2025
Deadline:16/09/2025
Application period has ended
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