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