PD Dr. Stephan Fricke
Project Lead
Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig
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Platform SaxoCellSystems
The generic 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. Today, such manufacturing processes require the support of 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.
SaxoCellSystems will develop a supporting automation platform for AI-assisted 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 generic 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.
Präzisionstherapie-Cluster
