Imagine baking a cake where you can't open the oven to check it without ruining the whole thing. This technology acts like a smart sensor that watches the 'cake' (the cells) constantly without touching them. It uses a digital twin to predict when the cells are perfect, removing the need for slow, manual checks by hand.
Cell and gene therapy production is too expensive and unpredictable because it relies on manual steps in clean rooms. This lack of scalability prevents millions of patients from accessing life-saving cures.
A self-contained analytical instrument for real-time sensing of critical process parameters, paired with digital twin models and prediction algorithms for process control.
If you are a therapy developer dealing with unpredictable outcomes and high manual labor costs — this project developed a self-contained analytical instrument that enables non-invasive real-time sensing. This reduces the need for manual sampling and helps scale production.
If you are a hardware provider dealing with the lack of standardized quality control in CGT — this project developed a disposable, single-use sampling unit adaptable to any bioreactor. This allows your equipment to support fully automated, closed-system manufacturing.
If you are a CDMO dealing with doses costing between €250k-€2m due to labor-intensive processes — this project developed prediction algorithms and digital twins. These tools allow for automated process control to increase product quality and lower costs.
Current manual processes contribute to single dose costs between €250k-€2m. By automating monitoring and removing manual sampling, the project aims to bring these costs down.
Yes, the project specifically aims to enable the biopharma industry to scale out CGT production through standardized, decentralized, and automated processes.
Based on available project data, the consortium has developed a self-contained instrument and prediction algorithms, but specific licensing terms are not disclosed.
The consortium is currently addressing market entry by performing biocompatibility and validation tests to ensure the devices and consumables are GMP compliant.
The system uses a disposable, single-use sampling unit designed to be adaptable to any bioreactor, allowing for a closed-system manufacturing process.
The consortium is heavily industry-driven with an 86% industry ratio, consisting of 6 companies and 1 university across 7 countries. With 5 SMEs involved, the group is structured for commercial agility and rapid technology transfer rather than pure academic research.
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