Method Development, Transfer, and Validation

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 or ELISA kits
  • 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

 

Method Transfer, Set-up, and Cross-Validation

  • Qualification and transfer from another laboratory or to new equipment within the same laboratory
  • 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
  • Performing cross-validation using unknown quality control samples and incurred samples

 

Method Validation

  • Fit for purpose full three-day LC MS or six-day ELISA based validation as per FDA guidance
  • Process stability including, short term bench top, autosampler, and freeze-thaw
  • Examination of method specificity, extraction recovery, carryover, matrix effect, matrix suppression, and other relevant parameters
  • Stability testing of drugs and biomarkers in biological matrices at various time points