Medical and Pharmaceutical Engineering

Development of new technologies for use in biomedical engineering

© Fraunhofer ITEM, Ulrich Froriep

The development of production technologies for innovative drugs – ATMPs and biologics – is a research field that has increasingly become a focus at Fraunhofer ITEM. Certain therapeutics, such as CAR-T cells, require personalized manufacturing processes. Development of the necessary production technologies, however, so far has not kept pace with the rapid biomedical progress. Fraunhofer ITEM researchers are seeking to establish scalable and robust technology platforms for the development and manufacturing of biologics. In the future, automated and digitally supported production technologies are to enable rapid, safe, and reliable development of such drugs as well as their production to the high standards of pharmaceutical manufacturing.

For in-vitro diagnostics, Fraunhofer ITEM is further expanding its existing expertise in the fields of single-cell analysis and liquid biopsy. By analyzing RNA and DNA from single cells, the researchers aim to gain additional information from the valuable clinical samples and to derive new therapeutic strategies from this information. The combination of multi-omics and functional data creates novel tailored analysis platforms for this purpose.

Another field of research establishes test methods that can be used to evaluate the long-term durability of implants. Key topics are the testing of active implants, such as evaluation of the long-term performance of neural implants, and test systems for functional implants, including ones with anti-infective or anti-fibrotic effects. The aim is to foster biomimetic approaches and reduce implant testing in animals. In view of the regulatory requirements for medical devices, it is particularly important to have a regulatory strategy in place as early as possible. The necessary conformity assessment can then be performed smoothly, accelerating time to market for new products. A comprehensive database of requirements and materials for optimized (re)certification of medical devices is being set up. 

Next Generation Risk Assessment

For the assessment of medical device safety, the researchers apply, among other methods, the new concept of next generation risk assessment. With this approach, they use modeling parameters that allow them to avoid laboratory experiments and animal testing in particular. They employ methods that are used primarily for risk assessment of industrial chemicals, such as TTC, read-across and QSAR.

Medical device development: recent projects and highlights

OsseoAcoustics

The OsseoAcoustics project enhances the push-out test with acoustic emission measurement to detect implant loosening at an early stage. This improves patient safety.

High-Performance Center

High-Performance Center for Medical and Pharmaceutical Engineering successfully concluded in 2024 and continues ites research in the RNApp Graduate Program.

Long Term testing of Neural Implants

Fraunhofer researchers are developing solutions to ensure the quality and durability of neural implants while accelerating their development and market entry.

 

Project 4D Haler

Intelligent Inhaler for new pharmaceutical active ingredients, such as biologicals, mRNA, genes, tissue- or cell-based formulations.

 

Press release / 3.6.2022

RNAuto project

Fraunhofer develops automated production technologies for mRNA-based drugs. 

Project archive

Here you can find more projects sorted by our research and development competences. 

Publications

  • Abdulbaki, A., Doll, T., Helgers, S., Heissler, H. E., Voges, J., Krauss, J. K., Schwabe, K., Alam, M. (2023). Subthalamic Nucleus Deep Brain Stimulation Restores Motor and Sensorimotor Cortical Neuronal Oscillatory Activity in the Free-Moving 6-Hydroxydopamine Lesion Rat Parkinson Model. Neuromodulation [Epub ahead of print]. doi: 10.1016/j.neurom.2023.01.014 https://www.sciencedirect.com/science/article/abs/pii/S1094715923000235?via%3Dihub
  • Aksu, M., Kumar, P., Guttler, T., Taxer, W., Gregor, K., Mussil, B., Rymarenko, O., Stegmann, K. M., Dickmanns, A., Gerber, S., Reineking, W., Schulz, C., Henneck, T., Mohamed, A., Pohlmann, G., Ramazanoglu, M., Mese, K., Gross, U., Ben-Yedidia, T., Ovadia, O., Fischer, D. W., Kamensky, M., Reichman, A., Baumgartner, W., von Kockritz-Blickwede, M., Dobbelstein, M., Gorlich, D. (2024). Nanobodies to multiple spike variants and inhalation of nanobody-containing aerosols neutralize SARS-CoV-2 in cell culture and hamsters. Antiviral Research 221: 105778. doi: 10.1016/j.antiviral.2023.105778 https://www.sciencedirect.com/science/article/pii/S0166354223002565?via%3Dihub  - Open Access
  • Nguyen, M. H., Onken, A., Wulff, A., Foremny, K., Torgau, P., Schutte, H., Hild, S., Doll, T. (2023). Computational Modeling of Diffusion-Based Delamination for Active Implantable Medical Devices. Bioengineering (Basel) 10(5). doi: 10.3390/bioengineering10050625 https://www.mdpi.com/2306-5354/10/5/625  - Open Access
  • Weissfuss, C., Wienhold, S. M., Burkle, M., Gaborieau, B., Bushe, J., Behrendt, U., Bischoff, R., Korf, I. H. E., Wienecke, S., Dannheim, A., Ziehr, H., Rohde, C., Gruber, A. D., Ricard, J. D., Debarbieux, L., Witzenrath, M., Nouailles, G. (2023). Repetitive Exposure to Bacteriophage Cocktails against Pseudomonas aeruginosa or Escherichia coli Provokes Marginal Humoral Immunity in Naive Mice. Viruses 15(2). doi: 10.3390/v15020387 https://www.mdpi.com/1999-4915/15/2/387 - Open Access
  • Willy, C., Bugert, J. J., Classen, A. Y., Deng, L., Duchting, A., Gross, J., Hammerl, J. A., Korf, I. H. E., Kuhn, C., Lieberknecht-Jouy, S., Rohde, C., Rupp, M., Vehreschild, M., Vogele, K., Wienecke, S., Witzenrath, M., Wurstle, S., Ziehr, H., Moelling, K., Broecker, F. (2023). Phage Therapy in Germany-Update 2023. Viruses 15(2). doi: 10.3390/v15020588 https://www.mdpi.com/1999-4915/15/2/588 - Open Access
  • Wittmann, J., Bunk, B., Korf, I., Wienecke, S., Spröer, C. (2023). Therapie-Phagen: Voraussetzung für die Anwendung geschaffen. Biospektrum 29(2): 222-222. doi: 10.1007/s12268-023-1917-8 https://link.springer.com/content/pdf/10.1007/s12268-023-1917-8.pdf - Open Access