Molecular Biology Services

Charles River performs a comprehensive array of genomics-based assays to support all phases of drug development, from discovery and preclinical studies through clinical trials, in either singleplex or multiplex formats.

We isolate and purify DNA and RNA from a variety of tissues, body fluids, and cells in culture. Our extraction procedures are optimized to provide the highest quality results; both quality and yield of extracted nucleic acid samples are assessed prior to being used.

  • SERVICES
    • Real-time quantitative and reverse transcriptase PCR
      • Nucleic acid-based therapeutic assessments, including biodistribution/shedding studies and quantitation of the transgene mRNA for gene and cell therapies
      • Gene expression analysis
      • Cytokine mRNA profiling in immune response
      • Biomarker assessment
      • CYP mRNA induction
      • Ex vivo mRNA profiling in liver
    • Molecular biology
      • Reporter gene assays
      • Genomic and plasmid DNA isolation
      • Residual mammalian DNA detection by hybridization analysis
    • Assay feasibility, development and validation
    • Biological sample analysis
    • GLP/non-GLP study designs and reporting
  • TECHNICAL CAPABILITIES
    • Real-time PCR platforms capable of supporting multiple fluorescent chemistries
    • Luminex®-based QuantiGene® system
    • Bioluminescent reporter gene assays
    • Allelic discrimination assays (TaqMan® probe chemistry)
  • BIODISTRIBUTION/SHEDDING STUDIES

    Gene and cellular therapy products are at the forefront of modern medicine, and Charles River has helped our partners in the preclinical development of many viral, plasmid or cell-based drug products.

    For each product, detailed biodistribution as well as shedding data are required by regulatory authorities. We combine our extensive experience in toxicology with our expertise in genomics to offer you advice and conduct robust biodistribution/shedding studies that meet the expectations of current regulatory authorities and guidelines. We can use diverse matrices from the whole panel of animal models and development states to investigate a wide range of compounds (vaccines, cells, plasmids, viruses, etc.).

    With a suitably qualified detection system (e.g., qPCR) and genomics-specific necropsy procedures, we can detect as little as five copies of gene or cell DNA in any tissue or fluid in any species. Additional expertise in specialty areas such as DART allows us to -perform complete investigations covering integration, expression, persistence, and shedding.

    qPCR validation studies include:

    • Precision/accuracy
    • Dynamic range
    • Detection limit
    • Inhibition monitoring
    • Specificity, selectivity
    • Matrix effect
    • Stability
    • Extraction yields