The so-called “Advanced Medical Therapeutical Products” (ATMP) are at the spearhead of individualized medicine and use cell or tissue samples of patients to treat particularly severe diseases very effectively. Production is currently characterized by many manual subprocesses and subsystems, and is therefore very cost-intensive. Such products are thus only available to a limited extent. Fraunhofer IESE is therefore applying the principles of smart automation to the complex processes of ATMP production.
With smart software, Fraunhofer IESE enables
- low-cost, modular, flexible, and safe production with “lot size 1”,
- the automation of development and production independent of the active ingredient for drugs or vaccines,
- compliance with the high safety requirements for pharmaceutical products with corresponding quality assurance, and
- manufacturer-independent and complete quality certification.
The Fraunhofer Innovation Cluster “Production for Intelligent Medicine” serves as the framework that combines the institutes’ biological and medical know-how in the production of cell and gene therapeutics as well as vaccines with expertise in automation technologies and the autonomous control of industrial processes.
Under the leadership of the Fraunhofer Institutes for Cell Therapy and Immunology IZI, Experimental Software Engineering IESE, Manufacturing Engineering and Automation IPA, Molecular Biology and Applied Ecology IME, as well as Industrial Engineering IAO, the researchers are transferring automation technologies into medical research and application in the manufacturing sector. The goal of the project in its first phase is to develop innovative concepts for the digital, AI-supported, robot-assisted, and automatic production of drugs such as cell and gene therapeutics as well as vaccines.