Small Molecules Non-GLP Bioanalysis

Method validation of small molecules mainly covers: verifying the selectivity and specificity of the analytical method, matrix effect, calibration curve (response curve), range (from lower limit of quantification (LLOQ) to upper limit of quantification (ULOQ)), accuracy, precision, carryover, dilution linearity, stability, and repeatability of sample re-injection, etc. Together, these steps ensure the reliability and accuracy of the bioanalytical method.

In the laboratory for high-throughput screening analysis of small molecules in vitro, we commonly use the following techniques:

• Cassette analysis: this technique accelerates the drug screening and optimization process by simultaneously analyzing multiple compounds.

• Multiplex LC technology: This technique improves analysis throughput without affecting LC separation efficiency by using multiple LC systems in conjunction with a single mass spectrometer.

• On-line SPE technology: Also known as the Trap and Elute mode, it can process a sample every 10 seconds at its fastest.

• Acoustic Ejection Mass Spectrometry: This innovative combination of sonic liquid handling and mass spectrometry technology pushes the analysis speed to a truly second-level range.

Our Non-GLP bioanalysis team has extensive experience in high-throughput drug screening and has established application platforms for the above technologies. We support early drug screening, in vitro pharmacokinetics, rapid analysis of biomarkers, and provide diversified and rapid bioanalysis solutions to accelerate the drug development process for our clients.