Pharmacelsus

In vitro & In vivo Toxicology Services

The Pharmacelsus service portfolio on in vitro and in vivo toxicology offers you a complete workflow to de-risk either your early stage drug discovery or late stage development programs. 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 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, TMRE, neutral red
  • Readout
    Viability, Mitochondrial Membrane Potential

Mitochondrial Toxicity

  • Test systems
    HepG2, HepG2-Oxphos
  • Analysis
    Fluorescence, luminescence
  • Indicator
    Resazurin, XTT, ATP, TMRE, JC-10
  • Readout
    Mitochondrial Membrane Potential
  • 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

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
  • Indicator
    Resazurin, ATP
  • Readout
    Viability
  • Format
    96-Well Plate/Plate Reader
  • Multiplexing of analytical endpoints available

Mutagenicity/ Genotoxicity

  • Ames test*
  • Ames MPFTM Penta I
  • Chromsomen aberration (human lymphocytes)*
  • Mouse lymphoma assay*
  • HPRT*
  • Micronucleus (human lymphocytes)*
  • *in cooperation. All studies are conducted according to national and international guidelines

Allergic Response

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

Skin/ Eye*

  • Skin corrosion (EpiDerm, Corrositex®)
  • Skin irritation (EpiDerm)
  • Skin sensitization (DPRA, LuSens)
  • Eye corrosion and irritation (BCOP, EIT, HET CAM)
  • *in cooperation. All studies are conducted according to national and international guidelines

In vivo Toxicology*

Species

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

Routes of Administration

  • Oral
  • Intravenous
  • Subcutanous
  • Dermal
  • Inhalation
  • 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

  • Multigeneration studies
  • Fertility and reproduction
  • Embryotoxicity
  • Pre/post-natal development

Pathology

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

* in cooperation. All studies are conducted according to national and international guidelines

Further toxicological assays are available on request.

Please contact us for your specific toxicology study!

For in vitro Toxicology

Dr. Stephanie Urschel
Head of Marketing & Sales
urschel@pharmacelsus.de

For in vivo Toxicology

Dr. Bettina Husen
Head of in vivo Pharmacology & Pharmacokinetics
husen@pharmacelsus.de