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.

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.

Participation of small and medium-sized enterprises (SMEs) is strongly encouraged and proposals should include a commitment for first deployment in the EU.

Where relevant, proposals are warmly invited to liaise with the Coordination and Support Action (CSA) project JOIN4ATMP, in view of creating complementarities and potential synergies.