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Optimising the manufacturing of Advanced Therapy Medicinal Products (ATMPs)

This call supports projects that aim to enhance and industrialize the production processes of Advanced Therapy Medicinal Products (ATMPs), such as gene therapies, somatic-cell therapies, and tissue-engineered products. The objective is to overcome manufacturing bottlenecks that hinder large-scale production, improve cost-efficiency, product quality, and regulatory compliance, and enable broader access to these innovative therapies in Europe.

The opportunity is focused on fostering a robust, scalable, and sustainable ATMP manufacturing ecosystem that aligns with EU industrial and health policies, promoting strategic autonomy and competitiveness.

Opening: 22 May 2025
Deadline(s): 18 Sep 2025

Expected Outcome

  • Demonstrated improvement in manufacturing yields, consistency, and cost-efficiency.

  • Enhanced scalability and robustness of ATMP production.

  • Regulatory pathways supported by compliant quality management systems.

  • Industrial ecosystems strengthened for sustainable ATMP development in the EU.

Scope

Projects should address one or more of the following:

  • Development of innovative, scalable manufacturing processes for ATMPs.

  • Automation and digitalization of production and quality control workflows.

  • GMP-compliant technologies and quality assurance tools.

  • Standardization and harmonization of production and release protocols.

  • Integration of AI and digital twins to monitor and optimize production.

  • Reduction of production costs and increase of reproducibility and accessibility.

Partnerships across academia, biotech, medtech, contract manufacturing organizations (CMOs), and regulatory stakeholders are encouraged.

Partner Requests

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