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Method Development, Validation, and Transfer

Our scientists utilize effective method development, transfer, set-up, and validation techniques to identify, separate, and quantitate drug and metabolites in biological fluids. We provide the following method based services.

Method Development

  • Reverse engineer and rapidly transition between species/matrices
  • Recommend equipment per molecule and sensitivity (LC-MS vs. ELISA)
  • Optimize sample preparation and instrument conditions
  • Iterate per target curve range, Cmax, Tmax, and AUC
  • Identify blank matrix, anticoagulant, reference and internal standard
  • Ensure analyte stability and apply stabilizer as necessary

Method Transfer, Set-up, and Cross-Validation

  • Qualify and transfer from another lab to new equipment/analyst
  • Modify if transfer failed due to incomplete or incorrect information
  • Adjust for robust and straightforward method validation downstream
  • Prepare calibration standards and quality controls plus perform a test run
  • Cross-validate using unknown quality control samples and incurred samples

Method Validation

  • Run fit-for-purpose full three-day LC-MS-MS or six-day ELISA validation
  • Evaluate method selectivity, specificity, sensitivity, precision, and accuracy
  • Ascertain process stability – short term benchtop, autosampler, freeze-thaw
  • Examine extraction recovery, carryover, matrix effect, and matrix suppression
  • Assess the stability of drugs and biomarkers in bio matrices during sample processing, analysis, and long-term storage at various time points

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