Biosafety Testing

Charles River provides the services required to conduct an expert assessment of the potential risk of biologically-derived animal health products. The requirements for biosafety testing are assessed on a case-by-case basis, but the key elements would include:

  • Demonstration that the source material is free from detectable adventitious agents.
  • Demonstration that the manufacturing process is capable of removing and/or inactivating adventitious agents.
  • Characterization of the product.
  • Demonstration that the stability of the product and, where appropriate, the cell line.

Charles River offers several assays to detect adventitious agents and other contaminants, including:

  • Specific and general virus testing
  • Detection of fungi, bacteria, mycoplasma and endotoxins
  • Measurement of residual DNA and protein levels in final product
  • Cell line identity tests, including DNA fingerprinting and isoenzyme analysis

We also conduct validation studies that quantify the ability of a manufacturing process to remove or inactivate adventitious agents. Our experience covers many types of manufacturing processes, product types and potential contaminants, including viruses, bacteria, TSEs, nucleic acids and proteins.

We offer the following services to assess the identity and consistency of biologically-derived animal health products:

  • DNA sequence analysis
  • Plasmid copy number determination
  • Electrophoresis
  • Isoelectric focusing
  • Peptide mapping
  • Mass spectrometry

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Leading the industry in the fields of reproductive toxicology, inhalation, infusion, bone research and other specialty toxicological assessments.