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PharmaPreclinical Services – PharmacelsusIn vitro & in vivo Toxicology

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. We offer in vivo non-GLP toxicology studies in-house with rodents, e.g. for the early evaluation of the toxicological potential of drug candidates during development. Thereby, we support all studies with the required bioanalytical analysis. Furthermore, GLP bioanalysis of samples from all animal species can be performed.

Your contact at Pharmacelsus

MUDr. Maria Li
Director Business Development

Mobile: +49 173 889 4288

Mail: m.li@gba-pharma.com

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

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
  • 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.

Business Development

Contact us!

To learn more about us and what we can do for you please contact our Director Business Development.

The experienced and highly committed Pharmacelsus team offers a variety of different services the following in Areas.

In vitro ADME

More

In vivo DMPK

G(C)LP & non-GLP Bioanalytics

Biomarker Services

In vitro & in vivo Pharmacology

Preclinical Services

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