Know what’s inside:
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.
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.
Your contact at Pharmacelsus
MUDr. Maria Li
Director Business Development
Mobile: +49 173 889 4288
Mail: m.li@gba-pharma.com
