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Darryl L. Goss joins Bioreliance Darryl L. Goss has been appointed Vice President, Toxicology/Laboratory Animal Diagnostic Services (LADS), a new executive position created to lead this newly formed Business Unit.
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Determining the safety of a product, whether it is a pharmaceutical, biopharmaceutical, medical device or pesticide, may also include demonstrating its genotoxic potential.

Gene Mutation

Back to Genetic Toxicology

Point mutations result from small changes in nucleotide sequence, including base-pair substitutions and frameshift mutations, some of which may be detected as changes in the conditions under which the mutant cell can grow. The bacterial mutation assays measure the ability of a test article to induce reverse mutations in selected histidine-requiring mutant strains of Salmonella typhimurium or tryptophan-requiring mutant strains of Escherichia coli. The mammalian mutation assays measure forward mutations at two different loci. These loci control the expression of thymidine kinase (TK) in mouse lymphoma cells or hypoxanthine- guanine phosphoribosyl transferase (HGPRT) in Chinese hamster ovary cells. In order to evaluate the effect of metabolism on the test article, such tests are performed in the presence and absence of exogenous mammalian liver enzyme preparations (S9).

Assays offered by BioReliance:

Mammalian Cell Gene Mutation Assays

  • L5178Y TK+/- Mouse Lymphoma Assay
  • Medical Device and Specialized L5178Y TK+/- Mouse Lymphoma Assays
  • Screening Assay Using L5178Y TK+/- Mouse Lymphoma Assay
  • CHO/HGPRT Gene Mutation Assay
  • In Vivo Mammalian Mutation Assays - Big BlueTM Mutation Assay System

L5178Y TK+/- Mouse Lymphoma Assay

Assay Description Protocol
ICH protocol - Duplicate cultures per dose level 704
OECD protocol - Single culture per dose level 700
Single culture per dose level with independent repeat 700001
OECD protocol - Duplicate cultures per dose level 702
Duplicate cultures per dose level with independent repeat 702001
ICH protocol - Duplicate treatment cultures per dose level 705

Medical Device and Specialized L5178Y TK+/- Mouse Lymphoma Assays

Assay Description Protocol
Biocompatibility testing of Medical Devices - Screening test 702201
Biocompatibility testing of Medical Devices - Full test 702200

Screening Assay Using L5178Y TK+/- Mouse Lymphoma Assay

Assay Description Protocol
Reduced volume modification of the Mouse Lymphoma Assay 702005
Screening mouse lymphoma protocol 702006

CHO/HGPRT Gene Mutation Assay

Assay Description Protocol
Duplicate cultures per dose level. 782
Duplicate cultures per dose level with independent repeat. 782001

In Vivo Mammalian Mutation Assays - Big BlueTM Mutation Assay System

Assay Description Protocol
In Vivo Mutagenesis 170
Sponsor-supplied tissues 171
 
for further information and enquiries please contact: info@bioreliance.com