Know what's inside.
CD-Leiste

In vitro & in vivo Toxicology Services

The GBA Pharma 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, IPS 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
  • Expression of toxicity markers, e.g. kidney and liver toxicity (Luminex)
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
  • 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
  • Indicator: Resazurin, ATP
  • Readout: Viability, optional quantification of liver tox. Markers via luminex
  • Format: 96-Well Plate/Plate Reader
  • Multiplexing of analytical endpoints available
Mutagenicity/ Genotoxicity
  • Test systems:
    Ames MPF™ Penta I
  • Analysis:
    Colorimetry
  • Readout:
    No of revertant colonies
  • Strains:
    Salmonella typhimurium and E. coli strains listed in OECD 471
  • ± metabolic activation
  • Format:
    384-Well Plate
  • OECD 471 and FDA compliant
Allergic Response
  • Test systems:
    Peritoneal mastocytes
  • Analysis:
    Absorption
  • Indicator:
    O-phtaldialdehyde
  • Readout:
    Histamine release
  • Format:
    96-Well Plate/Plate Reader

In vivo Toxicology*

Species
  • Rodents and larger species
    (please contact us)
Routes of Administration
  • Oral
  • Intraperitoneal/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)

Further toxicological assays are available on request.


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

Brands of
GBA GROUP PHARMA