Fraunhofer ITEM - Human Health Research

Human health is the focus of research at the Fraunhofer ITEM. Topics covered in the area of preventive medicine include studies and risk assessments in environmental and occupational toxicology and consumer protection. In addition, research into cause-and-effect processes and development of methods and concepts for disease diagnosis and therapy play an important role.

The institute has pooled its competences to form four business areas:

1. Drug Research and Development, Medical Biotechnology and Molecular Medicine
2. Clinical Airway Research
3. Occupational and Environmental Toxicology and Consumer Protection
4. Testing and Registration of Chemicals, Biocides and Pesticides

The respiratory tract is the focus of research at the Fraunhofer ITEM. In in vitro and in vivo models, primarily substances that are taken up via the airways are studied. These include single components, such as fibrous dusts or ultrafine particles and nanoparticles, but also complex mixtures that are encountered at the workplace or in the environment, as for instance exhaust gases from automobiles and coking plants, or bitumen fumes.

The institute disposes of the technical equipment and facilities to reproducibly generate a large variety of atmospheres, which can then be investigated in allergological and toxicological studies (reproductive toxicity, carcinogenicity, and genotoxicity), as far as possible in in vitro test systems, or else in animal models. Appropriate animal models allow e.g. the influence of different substances on lung function to be evaluated. Methods of biochemistry, molecular biology, immunotoxicology, and histopathology are deployed to elucidate mechanisms of action.

The Fraunhofer ITEM performs toxicological and safety pharmacological testing for drug registration in compliance with good laboratory practice (GLP) regulations, a focus being placed on drugs administered by inhalation. For safety pharmacological studies, lung function tests can be conducted in appropriate animal models.

For the registration of pharmaceuticals for the indications allergy, asthma, and COPD, the Fraunhofer ITEM conducts clinical studies phases I-IV in compliance with good clinical practice (GCP) guidelines, managed by highly qualified physicians. The special equipment the institute disposes of for these studies includes different environmental exposure units for investigations in volunteers.

The "Fraunhofer Environmental Challenge Chamber" is used to expose test subjects e.g. to grass pollen. To allow for aseptically manufactured clinical investigational drugs to be used directly in the clinical trials performed at the Fraunhofer ITEM, a clean-room laboratory was set up in compliance with good manufacturing practice (GMP regulations). The required manufacturing authorization is expected to be granted in 2009.

Services offered by Fraunhofer ITEM

– Bioavailability studies
– Research on DNA adducts
– Studies on the effects of harmful substances on lung function (e.g. in asthma and allergy models)
– In vitro tests for toxicological and genotoxicological effects of inhalable, airborne substances
– Aerosol measurement and characterization, as well as creation of aerosols for experimental investigations
– Toxicological and ecotoxicological assessments
– Toxicological investigations (according to OECD guidelines and GLP standards) and special investigations, e.g. on mechanisms of actions
– Investigations to elucidate the mechanisms of action in allergic inflammation
– Analysis of lung physiological, immunological, molecular biological, and histological parameters in murine models of allergic asthma
– Studies on possibilities of drug administration by inhalation
– Elucidation of mechanisms of action on the cellular and sub-cellular levels
– Bioanalytical investigations (metabolites, protein and DNA adducts, biomonitoring)
– Investigation of novel animal models using diagnostic radiology and molecular imaging (µCT and µPET)
– Identification of biomarkers for various diseases
– Molecular diagnostics of gene polymorphisms
– Experiments on signal transduction and on regulation of gene expression
– Chip-based gene expression analyses
– Haplotype analyses
– Chemical screening of raw extracts from plants, bacteria, fungi, and animal organisms using LC-NMR-MS
– Pre-clinical studies on pharmaceuticals (general toxicology, reproductive toxicology, immunotoxicology, genotoxicology, in compliance with GLP regulations)
– Pre-clinical studies on pharmaceuticals in juvenile animals (juvenile toxicology)
– Studies on sub-chronic and chronic effects, in particular with regard to tumor formation and teratogenic effects
– Toxico-/pharmacokinetic studies on the absorption, distribution, and metabolism of pharmaceuticals in the organism, in organs, or in cell systems
– Clinical trials (phases I-IV, under GCP conditions) for the indications allergy, asthma, and chronic bronchitis
– Inhalation challenge tests with allergens, particles, ozone, and endotoxin
– Testing of exogenous substances for their toxic, allergenic, and irritant potentials
– In vitro testing of pharmaceuticals in allergy models from human dendritic cells
– Safety pharmacological tests in rats and mice (lung-specific)
– Pharmacological efficacy studies in viral, bacterial, and fungal infection models of the lung
– Studies on the effects of pharmacological agents on lung function (e.g. in asthma and allergy models)
– Studies in molecular toxicology
– Studies in molecular medicine and pharmacogenetics

Contact:
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
Marketing & PR
Nikolai-Fuchs-Straße 1
30625 Hannover, Germany
Tel: +49 511 5350-0
Fax: +49 511 5350-400
info@item.fraunhofer.de
http://www.item.fraunhofer.de