Personalised healthcare with advanced therapy medicinal products, so-called ATMP, forms a milestone in the treatment of complex illnesses, such as cancer. So far, these ATMP are largely produced manually, which is both time-consuming and expensive and, moreover, production is only possible for a limited number of patients. At the current time, this severely limits the availability of innovative therapeutic agents for patients who urgently need them.  

In parallel with this, the most recent case of the COVID19 pandemic has shown the tremendous challenges which arise in the context of the development and subsequent production of specific vaccines to respond to novel health risks.

This is where the Fraunhofer “Production for Intelligent Medicine” innovation cluster comes in – bringing together the biological and medical know-how of the institutes in the production of cell and gene therapeutics as well as of vaccines using 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 scientists are aiming to transfer automation technologies to medical research and applications in the production sector. In its first stage, the project aims to develop innovative concepts for the digital, AI-supported, robot-assisted and automatic production of pharmaceuticals as well as cell and gene therapeutics and vaccines.

Increasingly, tailor-made therapeutic strategies are raising hope for improved treatment success, e.g. in oncology. In consequence, this Fraunhofer innovation project pursues the aim of dramatically increasing the availability and quality of state-of-the-art personalised cancer and immuno-therapies as well as of vaccines. Moreover, automation technologies can also help in drastically reducing costs of production and, ultimately, significantly alleviate the burden on our healthcare systems.

With smart software, Fraunhofer IESE will ensure cost-effective, flexible, and safe production of intelligent medicine: In the Innovation Cluster, the institute will transfer its competencies from the areas of Industrie 4.0 and lot size 1 to the automated manufacturing of medical products. With the help of the reference architecture BaSys 4 developed in-house and the associated open-source middleware BaSyx, Fraunhofer IESE will not only make conventional production lines of discrete manufacturing fit for the future, but also the production of individualized medication. This will revolutionize the manufacturing of ATMPs from the ground up. The institute will also optimize the safety aspect of pharmaceutical products with its software-supported quality assurance, which enables manufacturer-independent and complete quality argumentation.  

Contacts:

Prof. Dr. Dr. Ulrike Köhl (Overall project management)

Dr. Thomas Tradler, MBA (Coordination)