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In vitro & in vivo Toxicology

Performed in-house in a quality controlled way

The Pharmacelsus service portfolio on in vitro and in vivo toxicology service offers you a complete workflow. De-risk either your early stage drug discovery or late stage development programs with us. In vitro toxicology assays are performed in-house in a quality controlled way. In vivo toxicology studies according to national and international guidelines are available on rodent and non-rodent species in cooperation with our trusted partner. In vivo non-GLP rodent studies are performed in house.

In vitro Toxicology

Cytotoxicity

  • Test systems
    • Established cell lines and primary cells, 2D–monolayer, suspension and 3D-organoid cultures
  • Analysis
    • Fluorescence, luminescence, absorbance
  • Indicator
    • Resazurin, XTT, MTT, ATP, LDH
  • Readout
    • Viability, Cell Membrane Damage, energy content

Mitochondrial Toxicity

  • Test Systems
    • HepG2, HepG2-Oxphos
  • Analysis
    • Fluorescence, luminescence
  • Indicator
    • Resazurin, XTT, ATP
  • Readout
    • Viability
  • Format
    • 96-Well Plate/Plate Reader
    • Multiplexing of analytical endpoints available

Metabolite Toxicity

  • Test systems
    • HepG2 w/ and w/o metabolic activation - by S9-Fraction
  • Analysis
    • Luminescence
  • Indicator
    • ATP
  • Format
    • 96-Well Plate/Plate Reader
  • Metabolite identification via LC-MS
  • Reactive metabolite trapping in liver microsomes

Immunotoxicity

  • Test Systems
    • PMBC, monocytes, blood
  • Analysis
    • Luminex technology
  • Readout
    • Lymphocyte subsets, cytokine levels
  • Format
    • 96-Well Plate/Plate Reader, Luminex
  • Can be combined with other systems e.g. viability assays
  • Recommended assays according to ICH S8

Hepatotoxicity

  • Test systems
    • HepG2, primary hepatocytes
  • Analysis
    • Fluorescence, luminescence, Luminex technology
  • Indicator
    • Resazurin, ATP
  • Readout
    • Viability, energy content, biomarker levels
  • Format
    • 96-Well Plate/Plate Reader, Luminex

Allergic Response / Histamine Release

  • Test systems
    • Peritoneal mastocytes
  • Analysis
    • Absorption
  • Indicator
    • O-phtaldialdehyde
  • Readout
    • Histamine release
  • Format
    • 96-Well Plate/Plate Reader

In vivo Toxicology*

Species

  • Rodents
  • Non-rodent species
    • (please contact us)

Routes of Administration

  • Oral
  • Intraperitoneal
  • Intravenous
  • Subcutanous
  • Dermal
  • Rectal
  • Others
    • (please contact us)

Acute Toxicity

  • Systemic toxicity
  • Phototoxicity
  • Local tolerance
  • Skin sensitisation and irritation
  • Others
    • (please contact us)

Subchronic & Chronic Toxicity

  • Rodents and non-rodents
  • DRF studies
  • MTD studies
  • Toxicokinetics

Reproductive Toxicity

  • Fertility and reproduction

Pathology

  • Histology
  • Immuno-histopathology
  • Others
    • (please contact us)

Further toxicological assays are available on request.

Please contact us for your specific toxicology study.

For In Vitro Toxicology

Dr. Julia Susewind
Project Manager ADMET & in vitro Pharmacology
susewind@pharmacelsus.de

For In Vivo Toxicology

Anika Christoffel
Team Manager in vivo Pharmacology
christoffel@pharmacelsus.de

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