A significant shift in safety assessment that can revolutionize the practice of regulatory toxicology is ongoing and includes reducing traditional toxicity testing in animals along with implementing higher-throughput testing schemes using human cell systems.
However, alternative testing platforms encounter significant regulatory hurdles and tentative acceptance by regulatory agencies and the scientific community, with qualification of each assay being the biggest challenge.
Despite this, there is a need to reduce reliance on animal testing by developing human-based biological models for genotoxicity safety and risk assessments.
The in vivo comet assay is expensive, inefficient, and laborious to score and can require up to 45-60 animals for each test article.
CometChip® is a single-cell array platform that facilitates rapid processing of 96 cell or tissue samples.
It utilizes an unbiased-automated image-based scoring system, allowing an entire 96-well plate, which can have over 200 scorable comets in each well, scored in less than 45 minutes.
Compare this to the days that are needed to score 96 samples using the 30-year-old, slide-by-slide, one cell at a time scoring system of traditional comet assays.
CometChip®, when combined with HepaRG™ cells, provides an opportunity to develop a New Alternative Methodology (NAM) to reduce reliance on the in vivo comet assay.
The CometChip® platform has been commercialized by Bio-Techne to provide researchers with consistent and reproducible results.
This webinar highlights ILS's pursuit to develop validate in vitro
toxicity testing and the role of the CometChip®
platform in this process.
Topics covered in this webinar include:
- Overview of the CometChip® platform
- Tools to evaluate comet assay results
- How developing a human-based biological model and using CometChip® can replace toxicity testing in animals
||Leslie Recio, PhD DABT
Vice President Research and Development
ILS (Integrated Laboratory Systems)
Recio is the Vice President of Research and Development at ILS.
He is responsible for guiding the development of new capabilities for novel approaches for assessing genotoxicity.
He also oversees research operations and provides overall scientific direction at ILS.
Recio received his M.S.
in Toxicology from the University of Kentucky.
He has published over 100 articles related to cytotoxicity, genotoxicity, and mutagenicity in peer-reviewed journals.
Additionally, he has served on the boards and has been elected president of several toxicology societies.
Recio is on the editorial board for Mutation Research – Reviews in Mutation Research and is an associate editor for Toxicological Sciences.
Cyrus Munshi, PhD
Manager, Biotech Antibody Development
Cyrus Munshi's scientific expertise encompasses biochemistry, pharmacology, cell signaling, antibody engineering and production of biologics.
He currently leads efforts to produce and engineer recombinant antibodies from multiple species.
In addition, he now leads the development of products relating to DNA damage and repair, more notably the CometChip®platform.
At Bio-Techne, Inc., he has also guided efforts to express difficult proteins in heterologous expression systems.
Prior to joining Bio-Techne, Cyrus pursued postdoctoral studies at the University of Minnesota and Ohio State University.
His postdoctoral experience covered three areas: (1) Structure, function and kinetics of campthothecin compounds for anti-tumor properties; (2) Calcium signaling through IP3-independent mechanisms mediated by cyclic ADP-ribose (cADPR) and nicotinic acid dinucleotide phosphate (NAADP); and (3)
Structure and function characterization of cyclases and CD38.
He is a co-author of more than 50 scientific publications, book chapters and proceedings.
Catherine McAvoy, Moderator
Product Marketing Specialist
Catherine McAvoy is the Product Marketing Specialist for the Antibodies and CometAssay® portfolio at Bio-Techne.
Catherine graduated from the University of Minnesota with a Bachelor of Science in Biochemistry.
She started in Technical Service and has since moved into Product Marketing.
Catherine has been with Bio-Techne since 2015.