PD Dr. Stephan Fricke
Project Lead
Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig
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Platform SaxoCellSystems
The production of ATMPs on an industrial scale requires automation solutions such as those used in the automotive industry, food production and the manufacture of conventional pharmaceuticals. In the future, automated manufacturing processes can benefit from machine learning algorithms to achieve continuous optimization. Initial concepts for automating batch-based production processes for high-throughput production of ATMPs have already been outlined. These will be further elaborated incorporating artificial intelligence (AI) and principles of classical unit production. All aspects will be developed with Good Manufacturing Practice (GMP) compatibility in mind and GMP training methods will be developed.
SaxoCellSystems will develop a supporting automation platform for manufacturing of cell products within the SaxoCell cluster. This will enable stakeholders to achieve robust scaling of cell production for clinical scale. For this purpose, standardized and reproducible protocols for automated bioreactor culture will be established. This standardization strategy will be achieved through an intelligent process model. In parallel, all aspects of intelligent quality management, such as tracking of the production materials used and quality controls, will also be incorporated into the automation. AI methods will be integrated to optimize the main and secondary processes in order to sustainably increase the efficiency of the processes.
Dr. Ulrich Blache
Coordinator
Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig
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Präzisionstherapie-Cluster
