GLP Chromatographic and Mass Spec Bioanalysis

Charles River offers substantial capacity and expertise in the highly sensitive and precise technique of chromatographic and mass spectrometric bioanalysis. We have validated the quantitation of NCE drugs, metabolites and biomarkers from a wide variety of biological matrices. Rapid sample analysis delivers reliable results on time for any project, ranging from nonclinical studies through Phase I-IV clinical programs. In addition to traditional pharmaceutical bioanalysis, our laboratories are equipped to handle industrial and agrochemical applications.

The scientists in our 7 laboratories located throughout North America, the United Kingdom and mainland Europe analyze over 250,000 samples per year. With decades of experience, our scientists collaborate directly with you, providing solutions tailored to your molecule and program.

Capabilities
  • High-throughput PK
  • Lead optimization, non-GLP PK
  • Method development, validation and rapid transition of methods between species and matrices according to regulatory guidelines
  • Method transfer/cross validation utilizing quality controls and/or incurred study samples
  • Watson LIMS™ data management
  • Nonclinical (GLP) and clinical (GCP) sample analysis
    • Nonclinical and clinical PK sample analysis
    • Bioequivalency studies
    • Therapeutic drug monitoring studies
    • Drug-drug interaction study support with validated multi-analyte methods
  • Biomarker measurements
  • GLP/GCP whole blood, plasma, serum, tissue, urine and cerebral spinal fluid sample analysis
  • Analyte stabilization techniques
  • Large molecule quantitation by LC-MS
    • Immunoaffinity capture
    • Digested
    • Multiple reaction monitoring (MRM) and intact MS
    • Peptides, proteins, oligonucleotides, antibody-drug conjugates
Platforms
Equipment

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