Genetic and Molecular Toxicology
The Genetic and Cellular Toxicology Program offers a battery of validated genetic toxicology in vitro cell based assays and in vivo assays to meet ICH S2A/S2B Guidelines and REACH testing requirements. The Genetic and Cellular Toxicology Program also has extensive expertise in the conduct of the Ames, micronucleus, and Comet assay and offers flexible protocols combining multiple endpoints with in vitro and in vivo tests. Mechanistically-based assays that are offered include primary cell culture systems, quantitative gene expression profiling, and toxicogenomic studies. Validated genetic toxicology testing conducted under GLP guidelines and novel technologies are integrated to meet the regulatory and research needs of our clients.
- ICH S2 (R1) Genetic Toxicology Battery
- Bacterial gene mutation (Ames) assay
- in vitro micronucleus and comet assays in human TK6 and HepaRG™ cells
- in vitro chromosome aberration assay
- in vitro TK mutation assay
- in vivo micronucleus, comet, and Pig-a gene mutation assays, including integrated testing protocols
- Robust flow cytometry-based assessment of micronucleus induction and Pig-a mutant phenotype
- CometChip technology
In vitro Toxicology
- Cell culture: primary rodent and human hepatocytes and established cell lines (e.g., hamster V-79 CHL and CHO; human TK6 and HepaRG™)
- Cytotoxicity assays
- Cell proliferation/viability assays
- Multi-endpoint (e.g., micronucleus and comet assays) in primary cells and cell lines
- Flow cytometry-based assay multiplexing
- Apoptosis assays (PCNA, BrdU)
- Validation of alternative test methods
- Stem cells (human induced pluripotent and embryonic stem cells) used as epigenetic models for predictive toxicology
Cheryl Hobbs, Ph.D.
Dr. Hobbs oversees the conduct of toxicology testing at ILS. She provides oversight for the acquisition of genotoxicity data for the National Toxicology Program and for genetic and investigative toxicology studies conducted for government and commercial clients according to Organisation for Economic Co-operation and Development (OECD) and regulatory guidelines. Prior to joining ILS, Dr. Hobbs was concurrently an Assistant Investigator in the Hematology/Oncology – Oncology Section at Lankenau Hospital in suburban Philadelphia and a Scientist at the affiliated Lankenau Institute for Medical Research, where she previously did her postdoctoral training. Before obtaining her doctorate, she worked as a molecular biologist in support of drug discovery programs at Sterling Winthrop, Inc. and cancer research at the Fox Chase Cancer Center. Dr. Hobbs has over 30 years of diverse experience with in vivo and in vitro models of disease and genetic damage incurred by chemical exposure. Her technical experience includes assay development/validation and many conventional molecular, cellular, and biochemical experimental techniques. She has published in the fields of genetic toxicology, gene regulation, and epigenetic mechanisms of disease and toxicity. She has been a member of several professional organizations, including the Environmental Mutagenesis and Genomics Society, the Genetics and Environmental Mutagenesis Society, and the American Association for Cancer Research, and has received research awards from federal, state and private funding agencies. Dr. Hobbs attained her M.S. and Ph.D. in Bioscience and Biotechnology from Drexel University and her B.A. in Biological Sciences and Computer Science from the University of Delaware.