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.

The Fraunhofer Institute for Molecular Biology and Applied Ecology IME conducts research in the field of applied life sciences from a molecular level to organisms, in the areas of pharmacy, medicine, biology and chemistry. Our mission is the development and use of novel technologies for diagnosis and therapy of diseases. Fraunhofer IME sites in Hamburg, Frankfurt am Main and Aachen are involved in the Fraunhofer Innovation Cluster, where they contribute their expertise in protein production for nutrient media, the cultivation of therapeutic stem cells and macrophages as well as respective quality controls, the preclinical development of therapeutics and the automation of these processes. The biologists, biotechnologists and physicians at Fraunhofer IME can rely on successful preliminary work in national and European funded projects as well as industrial projects^[1], such as the establishment of protocols for the differentiation of stem cells, the automated and high-throughput-compatible generation of homogeneous 3D stem cell preparations, the recombinant production of growth factors and the implementation of clinical studies.

Prof. Dr. Dr. Gerd Geisslinger, the managing director of the Fraunhofer IME and spokesman for the Fraunhofer Group for Life Sciences, is certain: “This project will make a direct contribution to innovative production processes in order to be able to provide broad sections of the population with individualized therapies in the sense of cost-intelligent medicine. Last but not least, this project will also strengthen Germany as a production location."

 

[1]

Witt G et al. An automated and high-throughput-screening compatible pluripotent stem cell-based test platform for developmental and reproductive toxicity assessment of small molecule compounds. Cell Biology and Toxicology Jun 20 (2020). doi: 10.1007/s10565-020-09538-0

Kikuchi-Taura A et al. Bone Marrow Mononuclear Cells Activate Angiogenesis via Gap Junction-Mediated Cell-Cell Interaction. Stroke Apr;51(4):1279-1289 (2020). doi: 10.1161/STROKEAHA.119.028072

Schwedhelm I et al. Automated real-time monitoring of human pluripotent stem cell aggregation in stirred tank reactors. Scientific Reports 9(1):12297 (2019). doi: 10.1038/s41598-019-48814-w

Tandon R et al. Generation of two human isogenic iPSC lines from fetal dermal fibroblasts. Stem Cell Research 33:120-124 (2018). doi: 10.1016/j.scr.2018.10.004

De Sousa PA et al. Rapid establishment of the European Bank for induced Pluripotent Stem Cells (EBiSC) - the Hot Start experience. Stem Cell Research 20:105-114 (2017). doi: 10.1016/j.scr.2017.03.002

 

Partners

• Fraunhofer Institute for Cell Therapy and Immunology IZI
• Fraunhofer Institute for Experimental Software Engineering IESE
• Fraunhofer Institute for Manufacturing Engineering and Automation IPA
• Fraunhofer Institute Molecular Biology and Applied Ecology IME
• Fraunhofer Institute for Industrial Engineering IAO
• Fraunhofer Institute for Production Systems and Design Technology IPK
• Fraunhofer Institute for Production Technology IPT
• Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
• Fraunhofer Institute for Industrial Mathematics ITWM
• Fraunhofer Institute for Chemical Technology ICT
• Fraunhofer Institute for Cell Therapy and Immunology, Branch Bioanalytics and Bioprocesses IZI-BB
• Fraunhofer Institute for Integrated Circuits IIS
• Fraunhofer Institute for Machine Tools and Forming Technology IWU
• Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB
• Fraunhofer Institute for Factory Operation and Automation IFF
• Fraunhofer Institute for Microengineering and Microsystems IMM
• Fraunhofer Institute for Surface Engineering and Thin Films IST
• Fraunhofer Institute for Microelectronic Circuits and Systems IMS
• Fraunhofer Institute for Silicate Research ISC
• Fraunhofer Research Institution for Marine Biotechnology and Cell Technology EMB
• Fraunhofer Institute for Process Engineering and Packaging IVV
• Fraunhofer Institute for Digital Medicine MEVIS
• Fraunhofer Institute for Optronics, System Technologies and Image Exploitation IOSB
• Fraunhofer Institute for Biomedical Engineering IBMT

Contacts:

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

Dr. Thomas Tradler, MBA (Coordination)