Regulatory safety and toxicology

A special focus of toxicological testing at Fraunhofer ITEM is on inhalation toxicology studies.
© Fraunhofer ITEM
A special focus of toxicological testing at Fraunhofer ITEM is on inhalation toxicology studies.

For risk assessment and registration, we offer toxicological, toxicokinetic, pharmacokinetic, and safety pharmacological studies in rodents and – in cooperation with other institutions – also in non-rodents. These studies are performed in compliance with the international ICH registration guidelines, under which we have been GLP-certified since 1991. A special focus is on inhalation toxicology studies, an area of expertise where we have several decades of experience and international reputation.

Overview of our services and expertise

For risk assessment and registration, Fraunhofer ITEM offers toxicological, toxicokinetic, pharmacokinetic, and safety pharmacological studies.
© Fraunhofer ITEM
For risk assessment and registration, Fraunhofer ITEM offers toxicological, toxicokinetic, pharmacokinetic, and safety pharmacological studies.
  • Regulatory assessment by means of standard tests in compliance with international guidelines (OECD, EU, EPA or FDA)
    • In-vivo studies (relevant species, single-dose and repeated-dose toxicity, safety pharmacology)
    • In-vitro studies (genotoxicity, molecular toxicity, screening tests)
  • Standard routes of administration, intratracheal, nose-only and whole-body inhalation exposure
    • Toxicokinetics, bioanalytics and formulation analytics
  • Histopathology
    • Immunohistochemical techniques
    • Cell proliferation assays (e.g. BrdU, PCNA)
  • Clinical chemistry and hematology
  • Genotoxicity
    • Ames test
    • Micronucleus assay
    • Comet assay
    • Chromosomal aberration test
  • Immunotoxicity
    • Endpoints in standard toxicity studies according to ICH S8
    • Weight-of-evidence review
    • Product-tailored additional studies on immune function and immunotoxicity
  • Safety pharmacology
    • Cardiovascular system: telemetered animals (in cooperation)
    • Central nervous system: functional observational battery, locomotor activity
    • Respiratory system: body plethysmography

Special inhalation toxicology portfolio

Fraunhofer ITEM has several decades of experience and international reputation in the field of inhalation toxicology.
© Fraunhofer ITEM
Fraunhofer ITEM has several decades of experience and international reputation in the field of inhalation toxicology.
  • Inhaled administration and toxicity assessment of:
    • Pharmaceuticals including small molecules, recombinant proteins, and non-standard products such as cell and gene therapies or bacteriophages
    • Nanoparticles and novel formulations
    • Poorly soluble particles
  • Complex project designs for adequate toxicological characterization
  • Guideline-compliant study performance
    • State-of-the-art inhalation and measurement equipment
    • Studies up to large scale with eight exposure groups in parallel
  • Nose-only and whole-body exposure
    • Generation of complex inhalation atmospheres (solids, liquids, volatiles, semi-volatiles, suspensions)
    • Suitability tests of aerosol generators for toxicity testing
    • Physical, chemical, and biological characterization of test atmospheres

Contact

Henning Weigt

Contact Press / Media

Dr. Henning Weigt

Group Manager

Phone +49 511 5350-329