BioPharma Product Testing EN >> Validated Standard Testing Methods >> Genotoxicity Testing

Genotoxicity Testing Strategy

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The testing strategy for genotoxicity covers three main areas:

  • Gene mutations
  • Chromosome aberration or breakage (clastogenicity)
  • Chromosome loss or gain (aneuploidy)

 

Current general strategy consists of in vitro assays capable of detecting all of these endpoints:

  • Gene mutations:
    • AMES (OECD 471) [link], Mouse Lymphoma Assay (OECD 490) [link], HPRT Test (OECD 476) [link]
  • Chromosome aberration or breakage :
    • Chromosome aberration Test (OECD 473, 475) [link]
  • Chromosome loss or gain:
    • Micronucleus Assay (OECD 478, 474) [link]

 

Possible follow-up evaluation (in case of positive results):

  • in vivo micronucleus test (OECD 474)
  • in vivo chromosome aberration test (OECD 475)
  • in vivo UDS Test (OECD 486)
  • transgenic mutagenicity tests (OECD 488)
  • in vivo Comet Assay (OECD 489) [link]
  • Comet with 3D-reconstructed human skin model
  • MNT with 3D-reconstructed human skin model

 

Genetic Toxicity Pharmaceuticals

 

 

 

Impurity Assessment Pharmaceuticals

 

 

 

Genetic Toxicity Medical Devices

 

 

Genetic Toxicity Chemicals

 

 

Genetic Toxicity Cosmetics