Home Uncategorized Expert Insights Into LC-MS/MS Biomarker Testing Services And Bioanalysis For Small Molecules

Expert Insights Into LC-MS/MS Biomarker Testing Services And Bioanalysis For Small Molecules

Biomarker labs use LC-MS/MS technique for quantifying small and large molecule drugs or biomarkers in biological fluids. An LC/MS technique is unique as it combines HPLC’c high resolving power with the superiority of MS’s mass detection capability. The LC/MS and LC-MS/MS bioanalytical techniques are well-sought after for their solution-oriented approach towards a spectrum of structural characterization problems and structural analysis of small molecules in pharmaceutical research. These include identification of metabolites, identification of trace level impurities and degradants in bulk drug substances, as well as identification of unknown components in synthetic reaction products. Because LC-MS/MS allows investigations at nanogram and picogram ranges, it provides greater sensitivity and superior specificity to its conventional counterparts.

Biomarker labs employ LC-MS/MS in drug bioanalysis at all drug developmental stages and biomarker assay development to submit high-quality data within pre-determined deadlines. They use validated LC-MS/MS methods for the simultaneous analysis of small molecules, detection of impurities, higher specificity, improved precision, and accuracy. The ever-increasing sensitivity has paved the way for the detection of smaller assay volumes. LC-MS/MS can be used for food analysis, determination of toxins in health supplements and drinking water, multicomponent analysis of pesticides in fruits, and detection of contamination of foodstuff with antibiotics.

The LC-MS technique can be divided into sample extraction, separation, and quantification. The sample extraction method is done using either liquid-liquid extraction, protein precipitation, or solid-phase extraction method. The technique implemented depends on the type of small molecules used in the bioanalysis. The PPT method comprises a matrix effect, which can be removed through LC-MS/MS method validation.

But LC-MS/MS must follow the same regulatory standards for method development and validation. The characteristics required for LC-MS/MS instrument method validation include precision, accuracy, specificity, linearity, quantification limit, matrix effect, recovery, and stability. Such validated characteristics ensure that they produce robust high-throughput analysis and pharmacokinetic sample analysis. Therefore, all LC-MS/MS techniques must be developed and validated according to the protocols or according to the Standard Operation Procedures (SOPs) to abide by the regulatory guidelines

Conclusion

Over the years, LC-MS/MS has emerged as a powerful and reliable technique in biomarker analysis. LC-MS/MS can be used for bioanalysis at all stages of pharmaceutical drug development due to its high sensitivity, specificity, accuracy and precision, and quick turn-around time.

LC-MS/MS techniques have numerous applications in the bioanalysis of small molecules. They can be used for high-throughput analysis for discovery studies, structural analysis of trace level impurities in drug substances and synthetic reactions, metabolite identification, characterization of therapeutic protein products for process improvement, food analysis, detection of pesticides, high-grade screening analysis, and PK studies sample analysis, method transfer and optimization, analytical methods for clinical trials.

The use of small molecules in drug testing and bioanalysisis predicted to rise. Although immunoassays provide a robust platform in the bioanalysis of small molecules, LC-MS/MS technology is more readily available. Hence, biomarker assay development and biomarker lab should equip themselves to meet challenges met during the refinement of an LC-MS/MS technique for biomarker analysis.

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