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