Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine

Mechanistic and in-vitro toxicology

We offer a broad range of in-vitro test methods that are used for pre-clinical testing of active pharmaceutical ingredients and for assessing the cytotoxic and genotoxic potentials of environmentally and occupationally relevant substances. This also includes alternative test methods in line with the current European chemicals policy (REACH). Selection of the appropriate cellular test systems and development of the study design is performed in consultation with the sponsor, governed by a variety of criteria such as relevance of the species, organ, and target site, endpoints to be analyzed, compliance with the relevant guidelines (e.g. OECD), and any additional requirements.

Overview of our services

© Fraunhofer ITEM

 

  • In-vitro exposure of cellular test systems
    Exposure to airborne, soluble, and particulate test substances
  • Determination of multiple parameters in cells
    Determination of endpoints and on-line monitoring
  • In-vitro ADME assays
    CYP450 monooxygenases, NAT profiling, biochemical parameters
  • Characterization of molecular mechanisms of action
  • Regulatory assessments by means of standard genotoxicological tests
    in compliance with international regulations (OECD, EU, EPA, FDA)

 

Methods

Biological test systems:

  • Primary cultures of human and animal origin, immortal and transgenic cell lines, co-culture systems, precision-cut liver and lung slices, microsomes

Exposure:

  • Liquid or soluble test substances
  • Particulate substances in suspensions
  • Airborne test substances (gases, aerosols, particles) in a special culturing and exposure system developed for this purpose

Detection of biological effects:

  • General toxicity (e.g. cytotoxicity, apoptosis, oxidative stress, proliferation, ATP status, interleukins, DNA damage, transcription factors)
  • Genotoxicity (e.g. comet assay, micronucleus assay, chromosomal aberration test)
  • Molecular mechanisms (expression of toxicologically relevant genes, epigenetics, and DNA analyses)

Assured quality

We are GLP-certified for toxicological studies according to the German guideline ChemVwV-GLP No. 5.3/OECD, including genotoxicity studies and molecular toxicological studies.

Contact

Tanja Hansen

Contact Press / Media

Dr. Tanja Hansen

Manager of the Working Group on In-vitro Test Systems

Phone +49 511 5350-226