PAT4CGT Project Delivers Real-Time, Non-Invasive Process Monitoring System for Scalable CGT Manufacturing
The PAT4CGT project has developed a fully automated, miniaturised analytical platform that enables closed and non-invasive monitoring of critical process parameters for cell and gene therapy (CGT) manufacturing.
The platform utilises advanced sensors, a novel bioreactor, and digital twin predictive algorithms to improve process control, reduce contamination risk, and streamline GMP-compliant production.
The system was benchmarked against commercial sensors while monitoring NK and CAR T cell cultures, demonstrating robust and reliable performance.
The Horizon Europe-funded PAT4CGT project has developed an automated, real-time monitoring platform that advances cell and gene therapy (CGT) manufacturing. The miniaturised analytical system enables closed, non-invasive, and data-driven production process monitoring, helping manufacturers scale up production while assuring GMP-compliance.
The platform integrates state-of-the-art sensors provided by Jobst Technologies, Limula’s novel bioreactor and digital twin predictive algorithms built by the Bioprocess Technology Research Group at TU Wien. Together, these components support continuous monitoring, automated data collection, and predictive modelling during the CGT manufacturing process. PAT4CGT’s innovation improves process control and documentation, reducing the risk of human error and minimising contamination risks by removing manual sampling.
The project’s solution addresses key bottlenecks in the CGT manufacturing process, namely, human intervention to monitor the development of cell cultures and the requirement for high-grade clean room facilities to maintain sterility. PAT4CGT’s sensor platform paves the way for scalable, cost-effective, and compliant production of advanced therapies.
The technology is already deployed within Limula’s LimONE Device for automated cell therapy production, supporting in-line monitoring to enable scalable and GMP-compliant manufacturing, in both biopharma and clinical environments.
Summing up the wider vision guiding this collaborative work, Luc Henry, CEO of Limula, stated:
“Automation is what will enable this life-saving treatment to reach more patients faster and at a sustainable cost. By bringing all the steps in a single device within a closed environment, we massively reduce the need for operator intervention and specialised cleanrooms, ultimately making cell and gene therapies more accessible to patients and cheaper to manufacture.”
Henry added:
“PAT4CGT’s sensor technology directly supports this vision by increasing process reliability through automation and the continuous, non-invasive monitoring of critical process parameters throughout the CGT manufacturing process.”
During prototype testing, the system was evaluated for its ability to monitor and benchmark NK cell and CAR T cell cultures against commercially available sensor technologies. The evaluation process included technology transfer to manufacturing sites, operator training, and benchmarking across multiple end-user settings.
Stemmatters, a contract development and manufacturing organisation (CDMO), oversaw the platform’s evaluation throughout these phases. Rachel Paterson, Associate Principal Scientist at Stemmatters, said:
“The PAT4CGT platform offered a robust and efficient solution for the evaluation, monitoring, and benchmarking of NK cell and CAR T cell cultures. Our comparative studies against established commercial sensors provided clarity on both performance and data integrity, supporting more informed decisions during critical manufacturing steps.”
Gerhard Jobst from Jobst Technologies added, “We are happy to see our unique Biosensor-enabled analytical offering further applied and verified in the CGT field. Perfectly aligned with our ambition and claim to deliver Sensing What Matters by Small Smart Solutions for Those In Need”.
By replacing many labour-intensive manual steps with automated, real-time, and non-invasive monitoring, the platform directly addresses major obstacles to the scalability of CGT manufacturing.
The successful conclusion of PAT4CGT represents a significant step towards realising widespread, cost-effective, and high-quality access to advanced therapies. The project lays the groundwork for future innovations in automated CGT production, supporting the growing needs of patients, developers, and manufacturers across Europe and beyond.
To arrange an interview or to speak with a member of the PAT4CGT project team, contact:
PAT4CGT: alan.drumm@crowdhelix.ie
Stemmatters: Rachel Paterson, Associate Principal Scientist and Project Manager, rlpaterson@stemmatters.com
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