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

Head of Staff Group Institute Strategy and Communication

Phone +49 511 5350-329