By combining its novel bioreactor with state-of-the-art sensors and predictive data intelligence, Limula will add significant value to its cell & gene therapy manufacturing solution, paving the way for in-process control for the production of highly personalised CAR T cancer treatments.
Lausanne-based start-up Limula SA is thrilled to announce that it has received a positive evaluation for a European Innovation Council (EIC) Pathfinder grant of €3.6 million, with an additional €1.1 million from the Swiss federal government's agency for education, research and innovation (SERI). The aim of the project is to develop a miniaturised sensor platform to enable automated and non-invasive monitoring of critical process parameters during the production of CAR T-cells and other highly personalised therapies.
Current cell & gene therapies (CGT) manufacturing methods suffer from an important technological dept and still rely on semi-automated processes in centralised high-grade clean room facilities. This lack of process scalability results in low throughput, limited global production capacity, and ultimately high costs, preventing many patients from having access to this next generation of cancer therapies. In-process quality control monitoring of cell culture is one key bottle-neck. It is off-line, open and manual, with a high risk of introducing human error and contamination.
To address this issue, the PAT4CGT project will build a process analytics technology solution to collect high-quality data, supporting better batch documentation and improved decision making during the production of these complex therapies. Limula joins forces with a consortium of internationally recognised academic and industry experts across 6 EU member states. Cutting-edge biochemical sensors provided by Jobst Technologies will be adapted and integrated with the novel cell processing platform developed by Limula. Prof. Christoph Herwig at the Technische Universität Wien will contribute its expertise in the development of digital twins and ‘intelligence’ predictive tool for biotechnology applications. Stemmatters and Exothera, two CDMOs offering services in CGT process development and cGMP manufacturing will perform in-depth evaluation of the resulting solution on a number of use cases.
The proposal entitled “Closed and automated online monitoring towards process control and improved decision making in cell and gene therapy manufacturing” was one of the 8 selected amongst the 132 submissions to the Pathfinder Challenge call for ‘Emerging technologies in cell and gene therapy’.