Medical and Pharmaceutical Engineering

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.

The High-Performance Center Medical and Pharmaceutical Engineering combines the expertise of the Fraunhofer institutes in Hanover, Braunschweig and Lübeck and intensifies their collaboration to turn innovative ideas into successful applications. One field of research is the development of innovative inhalation technologies. The current focus is on the development of novel technologies for administration of therapeutic aerosols towards smart drug/device combination products.

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. 

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.