A – Translational Biomedical Engineering
Development of medical devices is a complex process taking place in a highly regulated environment. Besides specific technical expertise in this area, compliance with the relevant regulatory requirements is of pivotal importance. In this environment, we conduct research, development projects, and device testing. Our Translational Biomedical Engineering team has many years of experience in the development of medical devices. The focus is on neuro-implants on the one hand, and on conducting and assisting the development of novel technologies for administration of medical aerosols on the other hand.
Close dovetailing with the institute’s other working groups with scientific or medical focuses allows the team to provide comprehensive support to clients in their development projects. By cooperating with both internal and external development partners from industry and academia, we quickly find flexible solutions for project-specific requirements. In the area of quality and risk management, we support qualification of external technology processes for medical devices.
B – Clinical Trials
Fraunhofer ITEM has many years of experience and expertise in the field of clinical airway research, complemented by a unique state-of-the-art infrastructure for performing clinical trials. Our focus of research is on airway diseases, in particular asthma, COPD, and allergic rhinitis, and on interstitial lung diseases, especially idiopathic pulmonary fibrosis (IPF). Other therapeutic areas have been added over the past five years, including atopic dermatitis, inflammatory diseases and vaccine studies.
At the Clinical Research Center Hannover (CRC Hannover), one of Europe’s leading-edge non-hospital clinical research centers, we operate in a collaborative working environment that includes outpatient clinics and overnight facilities for study participants, advanced medical equipment, magnetic resonance imaging (MRI) systems, and a state-of-the-art biobank for storing biological samples.
In cooperation with our partner at the CRC Hannover, the Hannover Medical School, we conduct clinical trials also in other therapeutic areas, mainly atopic dermatitis, psoriasis, and sleep disorders.
Fraunhofer ITEM scientists have developed a wide range of challenge models to test the human response, for example, to inhaled allergens (inhaled allergen challenge; Fraunhofer Allergen Challenge Chambers in particular). We have direct access to human samples such as bronchoalveolar lavage (BAL), sputum, serum, and plasma, and have our own immunological lab where we have access, for example, to flow cytometry and chip cytometry and can perform ultrasensitive biomarker measurements on an MSD multiplex platform.
A large database of both prescreened patients (with asthma, allergic rhinitis, COPD, atopic dermatitis, or idiopathic pulmonary fibrosis) and healthy volunteers and a professional recruitment team ensure reliable time lines in the performance of clinical trials. Our research department furthermore has access to five challenge chambers – the Fraunhofer Allergen Challenge Chambers in particular – for proof-of-concept studies with sophisticated study designs using natural pollen (grass, birch), allergen extracts (e.g. cat, house dust mite), ozone, or hypoxia.
The Energetic Materials Department is concerned with all aspects of the development, manufacture and application of propellants and explosives. Beside defense applications, security research is becoming increasingly important in the civil sector.
Research fields in the area of nanoporous materials include imprinted polymers which can function according to the lock-and-key principle, thus enabling the development of (for example) selective sensors, and metal-organic framework structures, for example for applications in the areas of gas storage, separation techniques and sensor technology. Current research projects include the EU/BMBF project “SENSIndoor” and the Fraunhofer cooperation “MOF2market”.
The primary aim of the Working Group for Functional Nucleic Acids – Aptamers is to develop new and innovative products that are based on aptamers. This involves both the generation, synthesis and functionalization of aptamers, as well as their integration in various applications. At the same time, the goal is to work closely with industry and research institutes.
Aptamers are mainly short single-strand DNA and RNA molecules that exhibit the special property – much like antibodies – of highly affine and highly specific binding to target molecules. The extremely wide range of uses for aptamers in analytical, diagnostic and therapeutic applications makes them highly universal binding molecules.
Special focus is given to the production of new aptamers using an automated in-vitro selection process and an efficient monitoring and management process, as well as the development of aptamer-based detection methods, such as strip tests or so-called aptasensors.