The ILS In Vitro Toxicology program offers cell-based and biochemical assays to assess cytotoxicity, genotoxicity, gene expression, enzyme induction and effects on the epigenome in several cell lines and primary hepatocytes for discovery, research and regulatory compliance purposes.
ILS offers a wide range of in vitro toxicology services, from expertise with cell cultures and biochemical assessment of cellular health status to TgX.DDI genotoxicity biomarker panel assessment and genotoxic vs. nongenotoxic Mode-of-Action (MOA) prediction.
We also handle metabolism enzyme induction in hepatocytes; MOA assessment utilizing Next Generation Sequencing (RNA-Seq); DNA damage assessment in HepaRG™ and hepatocytes; and a broad range of genotoxicity MOA assessments.
We apply our extensive expertise in computational, cellular and molecular toxicology to conduct research and regulatory in vitro toxicology testing in a timely and efficient manner. And we have the research and regulatory experience to institute effective processes and work with you to design custom solutions for specific needs.
With a large number of pre-clinical candidates to sift through, time and money are of the essence. ILS can provide data for decision making and understanding MOA of potential adverse effects, reducing reliance on animal testing and focusing on direct relevance to humans.
Key data are integrated using computational approaches for species read across, facilitated by staff expertise in evaluating TOX21 cell-based assay data sets. We use state-of-the-art technology to assess whether a genotoxic response in human TK6 cells is due to a clastogenic or aneugenic MOA — a key issue for risk assessment. Metabolically competent HepaRG™ cells are used as a follow-up to positive genotoxic responses in the in vitro genetic toxicology test battery to reduce animal use.
ILS staff also have the scientific expertise to provide a comprehensive investigative toxicology approach to assess MOA by integrating computational tools with a broad spectrum of in vitro test systems using both traditional apical endpoints and novel approaches. ILS has published many findings related to MOA in peer-reviewed literature, on topics including OECD test guideline compliant regulatory testing, mechanistic studies on pathways of detoxication and use of genotoxic versus nongenotoxic MOA biomarkers.