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Optimising the Manufacturing of Advanced Therapy Medicinal Products (ATMPs)

This funding call aims to support the development of innovative manufacturing processes for Advanced Therapy Medicinal Products (ATMPs), enabling the European Union to strengthen its health industry. The call seeks to address key challenges in ATMP production, including scalability, cost reduction, quality control, and environmental impact. Proposals should focus on refining manufacturing processes for one category of ATMPs as defined by Regulation 1394/2007, with an emphasis on leveraging platform technologies, digital tools, and Artificial Intelligence solutions. Applicants are encouraged to demonstrate measurable impacts on manufacturing timelines, costs, and quality. Collaboration across academia, industry, SMEs, and healthcare providers is emphasized, and proposals should ensure regulatory alignment and sustainability in production processes.

Opening: 22-05-2025
Deadline(s): 18-09-2025

Data provided by Kooperationsstelle Wissenschaft

This funding opportunity represents a pre-agreed draft that has not yet been officially approved by the European Commission. The final, approved version is expected to be published in the first quarter of 2025. This draft is provided for informational purposes and may be used to preliminarily form consortia and develop project ideas, but it is offered without any guarantees or warranties.

Expected Outcome

• Accelerate ATMP development processes for unmet medical needs
• Enable faster patient access to high-quality ATMPs
• Strengthen EU industry competitiveness in ATMP manufacturing
• Establish academic centres of excellence in ATMP production
• Promote sustainable and environmentally friendly production methods

Scope

• Develop innovative manufacturing processes for ATMPs
• Integrate platform technologies and digital tools such as AI
• Focus on cost and timeline reductions while maintaining quality
• Address scalability, batch-to-batch consistency, and flexible manufacturing
• Collaborate with key stakeholders, including healthcare providers and regulators

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