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 engineering and rapid transition between species as well as matrices
  • Equipment selection based on molecule and sensitivity requirements, e.g., LC-MS-MS or ELISA kits
  • Selection of proper sample preparation technique
  • Instrument optimization for relevant parameters, e.g., mass spectrometer ionization
  • Considerations for target curve range, Cmax, Tmax, AUC as requested or published
  • Identification of an appropriate blank matrix, anticoagulant, reference standard, and stable labeled internal standard as applicable
  • Ensuring analyte stability under sample handling conditions, and using stabilizer if necessary

Method Transfer, Set-up, and Cross-Validation

  • Qualification and transfer from another laboratory or to new equipment/analyst within the same laboratory
  • Modification due to unsuccessful transfer due to incomplete or incorrect information
  • Adjustments of equipment conditions for robustness and straightforward method validation downstream
  • Preparation of calibration standards and quality control samples as well as performing a test run
  • Cross-validation using unknown quality control samples and incurred samples

Method Validation

  • Fit for purpose full three-day LC-MS-MS or six-day ELISA based validation as per FDA guidance
  • Assessment of method selectivity, specificity, sensitivity, precision, and accuracy
  • Process stability including, short term bench top, autosampler, and freeze-thaw
  • Examination of extraction recovery, carryover, matrix effect, matrix suppression, and other relevant parameters
  • Stability assessment of drugs and biomarkers during sample processing, analysis, and long term storage within biological matrices at various time points