In Vitro Toxicology

Vectura Fertin Pharma Laboratories has established and validated assays for in vitro safety assessment of novel chemical entities or biologics.

GLP Genotoxicity Studies

Assessment of genotoxic potential is an important step towards the registration of novel pharmaceutical agents. Industry guidance documents suggest a battery of tests including a bacterial gene mutation assay and an in vitro mutagenicity assay in mammalian cells, followed by an in vivo test for mutagenicity, such as an micronuclei assay. In alignment with these recommendations, we perform the following panel of in vitro assays and generate important data on genotoxicity prior to in vivo testing.

Ames assay (OECD TG 471)

Mutagenicity is assessed by the ability of a test chemical to reverse mutations within the histidine operon of selected bacterial strains, enabling the strains to grow on agar plates with minimal histidine supplementation.

Micronucleus assay (OECD TG 487)

Chemical mutagenicity is assessed by observing the formation of micronucleus following treatment of cells with the test item (human and non-human mammalian cells). Micronuclei MN are membrane-bound DNA fragments resulting from the activity of both clastogenic and aneugenic chemicals.

Mouse lymphoma assay (OECD TG 490)

This test evaluates chemical mutagenicity events that result in alterations at the thymidine kinase (Tk) locus in mammalian cells (e.g., L5178Y TK+/- mouse lymphoma cells). Gene mutations or chromosomal events at the TK locus result in viable colonies that are detectable when TK-/- cells are grown in medium containing trifluorothymidine (TFT, a pryimidine analogue).

GLP Cytotoxicity Studies

In vitro cytotoxicity testing is important for early-stage non-clinical testing to guide decisions on potential in vivo toxicity or dosage decisions for subsequent in vivo studies.

Neutral red uptake assay

This assay assesses the effect of test compounds on cell viability by measuring the cellular uptake of the dye neutral red by living cells. Neutral red accumulates in lysosomes/endosomes in living cells but not in dead/dying cells.

WST-8 assay

Overall cell viability and proliferation is assessed by measuring the reduction of tetrazolium salts to a colored water-soluble formazan product whose spectrophotometric absorbance is proportional to the number of viable cells present.

Non-GLP Methods

Liver Toxicity

  • Liver toxicity assessment following acute and chronic exposure
  • Assessment of  liver function markers (albumin, ALT, and AST) as well as ATP
  • 2D and 3D liver models

Drug-drug Interaction

  • Assessment of cytochrome P450 (CYP) activity after acute or chronic exposure to compound

Additional In Vitro Assays

At Vectura Fertin Pharma Laboratories, our in vitro scientists are available to develop additional in vitro assays to suit your research objectives. This includes:

  • Development of cell-based assays (luminescence-, absorbance-, or fluorescence-based)
  • Development of test systems and test systems characterization

Assay panels are important for early identification of potential hazards of your test items and are important preliminary screening tools prior to in vivo assessment. We have established numerous assays for assessing viability and mutagenesis, as listed below.

At Vectura Fertin Pharma Laboratories, your research goals are our priority