MBR Introduces First Assay Screen for GLP Ames Test
Contract Pharma- May 2007
Midwest BioResearch, LLC (MBR) has introduced a novel microAmes screen that fully predicts the GLP regulatory Ames test (Salmonella/E. coli Mammalian Microsome Reverse Mutation Assay). According to the company, the screen is accurate, rapid, and flexible, offering a cost-effective solution for drug discovery and development through smarter decision making during lead optimization.
Evaluating compounds for mutagenic potential using the GLP regulatory Ames test is required for most small molecules prior to conducting first-in-human studies. However, producing well-characterized test material of sufficient quantity to conduct this test takes a significant investment in chemical synthesis and, running a full plate GLP Ames test can take months to complete. MBR can screen for Ames mutagenicity in two weeks or less using approximately 5-10 mg of chemist bench sample. By relying on experienced experts, MBR generates an accurate answer on Ames mutagenicity during lead optimization, according to the company.
MBR’s microAmes uses all five Salmonella and E. coli tester strains recommended by regulatory agencies and evaluates colony formation, cytotoxicity and compound precipitation using an agar format-factors that make this screen the most predictive mutagenicity screen for the regulatory GLP Ames assay.
MBR also offers a micro-clastogenicity screen for predicting the regulatory GLP chromosomal aberration assay. According to the company, it provides the same speed, low compound requirements (10 mg), and cost advantages of the microAmes.
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