E!7384 RHYTHMS Region Skåne
| Reference number | |
| Coordinator | Region Skåne - Skånes Universitetssjukhus |
| Funding from Vinnova | SEK 2 000 000 |
| Project duration | March 2025 - March 2028 |
| Status | Ongoing |
| Venture | Eurostars |
Purpose and goal
RHYTHMS aims to develop a solution for improved process control and decentralized cell manufacturing for advanced therapies. Producing high numbers of high-quality cells with minimal batch variability is a challenge. The objective of the project is to develop a "toolkit" that improves process control in GMP-compliant iPSC cultures for cell and gene therapies, which have significant potential to treat incurable diseases and improve the quality of life for patients.
Expected effects and result
RHYTHMS will deliver a cost-effective sensor module for measuring critical nutrients in bioreactor derived cell cultures. An innovative software module enables advanced process control for decentralized manufacturing. With significantly improved standardization, more stable and sustainable production is expected, with fewer failed experiments for challenging cell types such as iPSC. Expected effects are more successful treatments, ultimately leading to improved patient health outcomes.
Planned approach and implementation
1) Project management, 2) Development of hardware module for sensors, including user requirements, proof-of-concept, prototyping, integration of hardware and software, testing and collection of user feedback, 3) Development of software module for control, including user requirements, process analytical development and user feedback, 4) Development of toolkit for GMP-3D iPSC production, including training, benchmarking, analytical testing, module validation and GMP-compliant documentation.