Limula takes Technical Lead of European Cell & Gene Therapy Project

Partners involved in the international consortium PAT4CGT have just been awarded a highly competitive EIC Pathfinder grant following a positive evaluation of their project proposal entitled ‘Closed and automated online monitoring towards process control and improved decision making in cell and gene therapy manufacturing’. PAT4CGT was recognized for its disruption potential, and ranked amongst the 8 projects selected out of the 132 submissions to the 2021 EIC  Pathfinder Challenge call for ‘Emerging Technologies for Cell & Gene Therapies’. Together, the partners will receive €3.6M from the European Commission, with an additional €1.1M from the Swiss federal government's agency for education, research and innovation (SERI). In addition Limula was able to secure proportional financial support in a €1.1m EUREKA Eurostars grant. 

Cell and gene therapies (CGT) represent a medical breakthrough in the treatment of a wide range of conditions. Highly personalized chimeric antigen receptor T-cell (CAR T) therapies were introduced in the clinic a decade ago, with spectacular results in patients suffering from previously incurable blood cancers. As more autologous CAR T-cell products enter clinical trials, there is a rapid increase in demand for clinical-grade cell products. However, current CGT manufacturing methods suffer from an important technological dept and still rely on semi-automated processes in centralized facilities. This lack of process scalability results in low throughput, high costs, and ultimately to limited global production capacity, preventing many patients from accessing this next generation of therapies. 

Disrupting cell culture quality control

In-process quality control monitoring of cell culture is one key bottle-neck. It is open and manual, with a high risk of introducing human error and contamination. To address this issue, the PAT4CGT project will develop a miniaturized sensor platform that automatically collects critical process parameters data and build an ‘intelligence’ predictive tool, paving the way towards real- time monitoring and improvements of CGT manufacturing processes.

Luc Henry, co-founder and CEO of Limula, explains: “There is a clear need in the CGT industry for process analysis technologies tailored for the one patient-one batch character of highly personalized cell therapies. We wanted to identify the best possible partners to complement our bioreactor technology and deliver the best possible solution to our customers. With PAT4CGT, we believe we bring together the right team.”

Expertise from Europe and Switzerland

The highly multidisciplinary collaboration will combine state-of-the-art sensors provided by Jobst Technologies, a novel bioreactor design developed by Limula, and predictive data intelligence in a closed and automated modular platform. The project will further leverage the academic expertise of Prof. Christoph Herwig at the Technische Universität Wien, contributing to the development of digital twins and predictive algorithms. End-user inputs and in-depth assessment of the resulting solution will be provided by Stemmatters and Exothera, two CDMOs offering services in CGT process development and cGMP manufacturing. This will result in high quality actionable information on the process status, supporting better batch documentation and improved decision making during the production of these complex therapies, with the potential to increase reproducibility.

The positive evaluation of the PAT4CGT proposal by the EIC is a strong validation of the mission of the consortium. The partners are brought together by a common vision to make CGT manufacturing more reliable by introducing automated, frequent and non-invasive, monitoring of critical process parameters. With over 2500 cell therapies in the oncology pipeline, it is the right time to develop reliable and scalable processes, ultimately significantly improving access to these revolutionary treatments through increased global production capacity.

(Press release - ES)