SolidCarT - Modular mini-factories for autonomous production of CAR-T cells

CAR-T cell therapies in the individualized treatment of patients with acute leukemias and lymphomas are a milestone in cancer therapy. With two marketable products, a breakthrough has been made in the commercial use of this technology. A challenge is posed by the non-standardized manual production process of these cells, as well as the so far less effective use of the cells in solid tumors. Current production processes are highly manual and therefore time-consuming and cost-intensive. Further challenges are quality assurance and prognosis of therapeutic success.

Within the scope of the project, it should be possible to produce CAR-T cells in a standardized form and with high quality at decentralized facilities such as university hospitals with the help of a "mini-factory". Standardization in production technology offers academic institutions the possibility of producing a large number of different cell preparations in a much shorter time, faster, at lower cost and with higher quality than has been usual on the market to date. Bile duct carcinoma is selected as the model tumor. Due to the large number of molecular target structures and the good results of initial studies, this entity represents a very suitable model. The interdisciplinary consortium forms the entire chain from process development to automated and digitalized production technology to new in vitro test methods for the detection of the effectiveness as well as in-line quality control. Within the scope of the project, a central module of the mini-factory for cell transduction and expansion is to be realized along the lines of Industry 4.0. In vitro test systems are to be developed to ensure 100% accuracy of fit of the therapies, and a clinical trial is to be implemented to enable testing of the optimized CAR-T cell preparations.