We automate cell-therapy manufacturing
Development of a bioreactor system for automated, GMP production of stem cells
The goal of the project is to automate the isolation, expansion and differentiation of adult stem cells acquired from biopsies of patients in three closed GMP devices, one per process step.
The project is divided into two main phases. In the first phase, the most suitable automation units are determined, developed and tested. In the second phase, the automation units are brought together forming the fully functional process-oriented devices.
The isolation device is focused on isolating the adult stem cells by digestion and purification steps. The cells are then passaged and expanded in larger T-flasks by the expansion device. Finally, the differentiation device is built to integrate the required mechanical, chemical, and/or electrical triggers needed for cell differentiation to ultimately manufacture the finished cell-therapy product.
These devices are controlled through a digital cloud-based web application automatically recording all process data, which is then accessible from anywhere, anytime. With such a digital and automated approach personnel, clean room, and production costs are reduced, allowing an easier market entry for cell-therapy products. Moreover, the modularity of the developed technology allows to adapt these devices to different stem cell-based processes and products.