Deadline: 16 September 2025
The European Commission is now accepting proposals for Optimising the Manufacturing of Advanced Therapy Medicinal Products topic.
Aims
- 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.
Scope
- 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.
- 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.
- Design an improved manufacturing process for ATMPs by:
- Participation of small and medium-sized enterprises (SMEs) is strongly encouraged and proposals should include a commitment for first deployment in the EU.
Funding Information
- Budget (EUR) – Year 2025: 40 000 000
- Contributions: 6000000 to 8000000
Expected Outcomes
- 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 in ATMPs.
Eligibility Criteria
- Entities eligible to participate:
- Any legal entity, regardless of its place of establishment, including legal entities from nonassociated 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.
- To become a beneficiary, legal entities must be eligible for funding.
- 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:
- Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.
- the Overseas Countries and Territories (OCTs) linked to the Member States:
- Aruba (NL), Bonaire (NL), Curação (NL), French Polynesia (FR), French Southern and Antarctic Territories (FR), Greenland (DK), New Caledonia (FR), Saba (NL), Saint Barthélemy (FR), Sint Eustatius (NL), Sint Maarten (NL), St. Pierre and Miquelon (FR), Wallis and Futuna Islands (FR).
- countries associated to Horizon Europe;
- Albania, Armenia, Bosnia and Herzegovina, Canada, Faroe Islands, Georgia, Iceland, Israel, Kosovo, Moldova, Montenegro, New Zealand, North Macedonia, Norway, Serbia, Tunisia, Türkiye, Ukraine, United Kingdom.
- the Member States of the European Union, including their outermost regions:
For more information, visit EC.