Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs)

The main goal of this opportunity is to support innovative activities that improve how Advanced Therapy Medicinal Products (ATMPs) are manufactured. The focus is on making these products more quickly and cost-effectively available to healthcare providers, researchers, and patients, especially for conditions with unmet medical needs. Key areas include advancing robust manufacturing processes, integrating new technologies like Artificial Intelligence, promoting sustainable and flexible production methods, and strengthening the competitiveness of the European health industry. Projects should also address product quality, regulatory compliance, and environmental sustainability. This grant primarily targets the European Union and Associated Countries, but legal entities in the United States are also eligible.

• Projects must follow the application format and page limits as required in the official application forms.
• Applicants must be established in eligible countries, including the EU, Associated Countries, and the United States (with some exceptions for certain non-EU/non-Associated Countries).
• Proposals are evaluated based on Excellence, Impact, and Implementation, achieving specified threshold scores.
• Projects must align with the expected outcomes, such as improving ATMP manufacturing, using innovative technologies, and supporting green production.
• Participation of small and medium-sized enterprises (SMEs) is strongly encouraged.
• If clinical studies are included, detailed information must be provided.
• Collaboration with certain EU initiatives and networks is encouraged for added synergies.

Examples:

• A project developing AI-driven quality control systems for ATMP manufacturing lines.
• A collaboration between SMEs and research centers to create a greener, faster cell therapy production process.
• An initiative to scale up patient-centric ATMP manufacturing using flexible, modular facilities in the EU.

• Personnel costs for researchers, engineers, and project staff
• Costs for equipment and laboratory materials directly used in the project
• Subcontracting specific research or technical tasks
• Travel and accommodation for project meetings and dissemination activities
• Costs for data management and digital infrastructure
• Consumables needed for manufacturing and testing ATMPs
• Costs for regulatory and quality assurance activities
• Expenses related to clinical studies (if included in the project)
• Communication and dissemination costs
• Overhead and indirect costs as allowed by the lump sum model

Restrictions: All expenses must be directly related to the project and comply with the lump sum funding rules of the Horizon Europe Programme.

• Budget for this Call: 40,000,000€
• Number of Grants attributed: 5 
• Maximum value per project: 8,000,000€
• Minimum value per project: 6,000,000€

• Applicants must be legal entities established in eligible countries, including EU Member States, Associated Countries, and the United States.
• Projects from legal entities in China are not eligible for Innovation Actions.
• Entities identified as high-risk suppliers for mobile communication networks are excluded from certain topics.
• Applicants must comply with any additional country-specific provisions as outlined in the Horizon Europe Programme Guide.
• If the project includes satellite-based earth observation, EU satellite systems must be used.
• The Joint Research Centre (JRC) may participate as a consortium member.
• Proposals should align with the expected outcomes and impacts described in the opportunity.