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LC-MS/MS

ICON’s dedicated method development teams have extensive experience developing and validating robust bioanalytical LC-MS/MS methods in plasma, urine, other biofluids and tissue samples to support pre-clinical and Phase 1 through Phase 4 clinical trials.

We support traditional small molecule analysis by LC-MS/MS, but also peptide and oligonucleotide analysis and protein measurements, either using signature peptides after enzymatic digestion, or in the intact form using High-Resolution Mass Spectrometry (HRMS).

Validation of bioanalytical methods is performed in compliance with international standards (ICH M10).

ICON offers a range of state-of-the-art Sciex mass spectrometers, ranging from API5000 to API6500+ and API 7500 instruments. Our laboratory in Assen also has a API6600 High-Resolution mass spectrometer (HRMS).

 

Services include:

  • Method transfer
  • Full method development
  • Method validation
  • Support of pre-clinical animal studies
  • Support of clinical trials (Phase 1 through 4)
  • Bioavailability studies
  • Bioequivalence studies
  • Drug-drug interaction studies
  • Microsampling (Wet and dried samples)
  • Metabolite screening & identification
  • Biohazard laboratory for infectious samples
  • Biomarker analysis
  • Protein binding studies

 

lab sampling

The use of hybrid LC-MS towards quantitation of soluble protein biomarkers

The article highlights the need for precise biomarker quantification to assess gene-targeting therapies. While ligand binding assays are common, researchers should evaluate the best method based on sensitivity, reagents, and detector selectivity to ensure therapeutic relevance.

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lab test tube sample

Utilisation of Hybrid LC-MS/MS for anti-drug antibody bioanalysis

As biotherapeutic technology advances, the need for adaptive, highly specific, and selective bioanalytical assays are necessary to measure immunogenicity. There are several evaluations used to test the immunogenicity against developed biotherapeutics that must be monitored in vivo given the variability of reactions that may occur from patient to patient.

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spectometry proteins

The use of high-resolution mass spectrometry for quantitative bioanalysis of proteins.

The use of high-resolution mass spectrometry offers a straightforward means to enhance the selectivity of protein quantification after enzymatic digestion.

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