Press releases

Nitrosamines (NAs) are a class of organic chemical compounds that humans may be exposed to by tobacco smoking or consuming certain foods. N-nitrosamines have been classified as probable human carcinogens and are categorized in the ICH M7 guideline as belonging to the “cohort of concern” group of high-potency mutagenic carcinogens. Some active pharmaceutical ingredients (APIs) carry NAs as impurities from production and/or storage or may cause their formation in the gastrointestinal tract.

The overall objective of the REMEDIA project is to determine to what extent environmental factors – the exposome – affect the severity and morbidity of chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF) throughout the disease. Its unique methodology relies on using atmospheric simulation chambers, integrating a unified clinical data repository and applying advanced machine learning approaches.

Worldwide, there is growing belief that biomedical sciences can advance with less animal testing by replacing in-vivo experiments with in-vitro models based on human cells or tissues. However, when it comes to elucidating disease mechanisms, especially at the organ and system levels, or to testing the efficacy and safety of drugs and medical devices, animal models are as yet indispensable. This is why researchers – also at the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM – are working to develop new human-relevant disease and test models according to the principle of the 3 Rs, both in vitro and ex vivo. The aim is to avoid animal experiments altogether wherever possible (replacement), to reduce the number of animals per experiment (reduction) and to keep their distress in experiments to an absolute minimum (refinement).

The European Commission asked for a feasibility study to be performed in the MONO4ERA project. In this study, Fraunhofer ITEM and partners identified, collected and analysed information to assess the feasibility of an active-substance-based approach (monograph system) and other potential alternatives.

Daniela Behrens, Lower Saxony’s Minister of Health and patron of the Health Prize, has honored three outstanding projects with the prize worth 15,000 euros. The Lower Saxony Health Prize promotes creative ideas and projects that are implemented exemplarily in the fields of disease prevention, health promotion and health care. The focus of this year's funding was on mental health, holistic physical exercise programs, and digitization or eHealth – special challenges for the health care system, especially in the second year of a pandemic.

Approximately 60 million patients worldwide suffer from chronic heart failure – a disease which in its advanced stages is associated with a rather limited life expectancy that is actually shorter than with many types of cancer. Chronic heart failure is a clinical syndrome involving not only the heart, but numerous other organ systems, especially the lung. In its recently published position paper, the European Society of Cardiology (ESC) gives an overview of interactions between the heart and other organ systems, clinical findings and underlying mechanisms and calls for more experimental research and the development of appropriate disease models to help understand the individual molecular mechanisms underlying heart failure. Through research based on models of cardiopulmonary diseases, researchers at the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM want to contribute to the development of new therapies.

Viruses are a major problem for human health worldwide – and this has not only been the case since the outbreak of the SARS-CoV-2 pandemic. Despite successful vaccine development, there are still no effective drugs available against most viral diseases – a situation that should be changed as quickly as possible. In the iGUARD (integrated Guided Ultrafast Antiviral RNAi Drug development) project, a team of researchers at the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM headed by Prof. Armin Braun will collaborate with Prof. Axel Schambach, head of the Institute for Experimental Hematology at the Hannover Medical School (MHH), to develop RNA-based active substances targeting viral diseases that can be adapted particularly quickly to different viruses and can thus provide protection against emerging infectious diseases. Together with eight other projects, this project was selected from 45 applicants in a Europe-wide research competition and is now being funded by the German Federal Agency for Disruptive Innovation (SPRIND), initially with 700,000 euros for one year.

For the second time already, Prof. Dr. Dr. med. Thomas Thum is one of the most frequently cited scientists worldwide. Once a year, the U.S. company Clarivate Analytics reports which publications in a particular discipline are among the one percent that have been cited most. Thomas Thum is a specialist in cardiology and bioscience, with a clear research focus on the functional characterization and translational potential of therapeutic RNA strategies, and his publications have had a major impact on the progress of cardiac research.

Advanced therapy medicinal products (ATMPs) are a new class of drugs comprising somatic cell therapeutics, gene therapeutics and bioengineered tissue products. To date, only a few such products have been approved throughout Europe. One reason for this is the lengthy and difficult path of their development. Prior to its use in humans, the safety of an ATMP must be demonstrated in a nonclinical phase in order to exclude potential side effects. Since ATMPs are of biological origin and thus exhibit high complexity and heterogeneity, individual testing strategies are required. The development of ATMPs from laboratory scale to manufacturing under Good Manufacturing Practice (GMP) conditions follows regulatory requirements.

How can viruses be effectively eliminated from indoor air? This question is now becoming more important as fall approaches. Efficient indoor air purification is essential, especially in schools. Fraunhofer researchers are investigating and optimizing various filter and air purification techniques in the AVATOR project.