Midwest Bio Research Drug Disposition and Toxicology Services
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Overview | Protein Bioanalysis | Small Molecule Bioanalysis | Genetic Toxicology | Program Services
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Genetic Toxicology

MBR's genetic toxicology group brings decades of Big Pharma experience to
help with the discovery and development of your lead or development drug
candidate. As former pharmaceutical company researchers, we understand the
importance of lead optimization using genotoxicity screens and delivering
regulatory-compliant, genetic toxicology reports on time, and within budget.
We can efficiently conduct and interpret genotoxicity tests during lead
identification and drug development.

Our genetic toxicology services team routinely conducts screens and regulatory-compliant tests using a variety of assay systems. When conducted to GLP, these assays are part of the standard core battery recommended by ICH and are adopted globally by regulatory agencies for pharmaceutical testing. Our industry leading services include:

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Overview

The core assays include:
  • Bacterial mutagenicity testing with Salmonella and E. coli strains (Ames test)
  • Chromosomal aberrations and micronucleus evaluations using mammalian cells (e.g., human lymphocytes, CHO)
  • In vivo micronucleus/chromosomal aberrations assessments in rodent hematopoietic cells
  • Novel screens for mutagenicity and clastogenicity features:
    • MBR exclusive microAmes screen that is highly GLP predictive for GLP regulatory Ames test mutagenicity
    • MBR exclusive miniaturized micronucleus clastogenicity test using human lymphocytes
    • Mimic regulatory assays
    • Miniaturized for use, only requiring 5-10 mg
    • Rapid throughput
    • Application for SAR within lead optimization

 

 
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