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Bioanalytical Services

Small and Large Molecule LC-MS

Liquid Chromatography-Mass Spectrometry (LC-MS) Bioanalysis

 Liquid chromatography-mass spectrometry (LC-MS) is a cornerstone of modern quantitative bioanalysis, supporting pharmacokinetic (PK) studies and regulated drug development. Its applications span small molecules, peptides, proteins, lipids, oligonucleotides, antibodies, antibody-drug conjugates (ADCs) and biomarkers.

IQVIA Laboratories combines over 30 years of bioanalytical experience with advanced capabilities including high-resolution mass spectrometry (HRMS) and multiplexed LC-MS assays. HRMS provides high-resolution, accurate-mass analysis and enhanced analytical selectivity, while multiplexing enables multiple analytes to be measured within a single analytical method.

Our LC-MS laboratories support programs from early preclinical studies through Phase III and bioequivalence trials, with scalable operations for hundreds to tens of thousands of samples and regulated bioanalysis conducted in accordance with GLP/GCP regulations and ICH M10 guidance.

Small Molecule Regulated Bioanalysis by LC-MS

 IQVIA Laboratories provides regulated LC-MS/MS bioanalytical services for small molecule drug development, supporting pharmacokinetic (PK), toxicokinetic (TK) and other quantitative bioanalytical studies from preclinical development through clinical trials.

Our scientists develop, validate and apply sensitive, selective and robust LC-MS/MS methods for the quantitative analysis of drugs, metabolites and biomarkers in biological matrices. From routine high-throughput sample analysis to programs requiring specialized analytical strategies, we deliver reliable, regulatory-compliant bioanalytical data to support confident drug development decisions.

Capabilities include:

  • 60+ triple quadrupole LC-MS systems dedicated to small molecule bioanalysis

  • PK/PD bioanalytical support for preclinical, nonclinical and clinical studies

  • Regulated bioanalysis conducted in compliance with GLP/GCP regulations and applicable global bioanalytical guidance

  • De novo assay development, method transfer and method validation

  • In-study sample analysis to support drug development programs

  • Automated sample preparation, including robotic handling and 96-well plate workflows for biological fluids and tissue pretreatment

Large Molecule Regulated Bioanalysis by LC-MS and HRMS

IQVIA Laboratories provides LC-MS-based bioanalytical services for the quantitative analysis of peptides, proteins and other large molecule therapeutics and biomarkers. Our scientists develop and validate fit-for-purpose and regulated LC-MS/MS methods, including workflows that combine selective sample preparation or immunoaffinity enrichment with mass spectrometry when appropriate. These approaches complement ligand binding assays by offering molecular specificity and analytical flexibility, enabling sponsors to select the bioanalytical platform best suited to the molecule, biological matrix and study objectives.

Capabilities include:

  • Substantial HRMS capacity for regulated bioanalysis: Fleet of validated high-resolution mass spectrometry systems, including, Thermo Excedion Pro, Thermo Orbitrap Exploris 480, and Thermo Q-Exactive instruments

  • Triple quadrupole LC-MS and HRMS approaches for quantitative large molecule bioanalysis

  • High-resolution, accurate-mass analysis for increased analytical selectivity

  • Nano-flow and low-flow liquid chromatography coupled with HRMS for highly sensitive analytical workflows
  • Multiplexed LC-MS analysis to monitor multiple analytes within a single analytical method
  • Automated bead-based immunoprecipitation to support sensitive and reproducible sample preparation workflows
  • Regulated bioanalytical capabilities designed to support complex drug development programs

Together, our significant investment in instrumentation and our collaborative scientific and expert approach provide flexible, sensitive and reproducible workflows to help excel today’s bioanalytical programs.

What is LC-MS used for in bioanalysis?

Liquid chromatography-mass spectrometry (LC-MS) is used for sensitive and selective quantitative bioanalysis across a range of drug modalities and analytes. Applications include pharmacokinetic (PK) studies, regulated bioanalysis, biomarker analysis and other bioanalytical applications throughout drug development.

What is the difference between LC-MS/MS and high-resolution mass spectrometry (HRMS)?

LC-MS/MS using triple quadrupole mass spectrometry is widely used for targeted quantitative bioanalysis. HRMS adds high-resolution, accurate-mass capabilities that can provide greater analytical selectivity and help differentiate target analytes from potential interferences. The appropriate approach depends on the analyte, matrix, sensitivity requirements and objectives of the bioanalytical program.

What types of molecules can be analyzed using LC-MS?

Our scientists apply LC-MS bioanalytical expertise across a range of analytes and drug modalities, including:

  • Small molecule drugs

  • Peptides

  • Proteins

  • Oligonucleotides

  • Lipids

  • Biomarkers

  • Antibody-conjugated modalities

These capabilities support the generation of quantitative bioanalytical data for regulatory submissions throughout drug development.

What are the benefits of HRMS for large molecule bioanalysis?

HRMS combines high mass resolution with accurate-mass measurement, providing increased analytical selectivity for challenging large molecule bioanalytical applications.

When working with complex molecules and biological matrices HRMS can provide additional analytical options by helping scientists:

  • Differentiate target analytes from potential interferences using high-resolution, accurate-mass measurements

  • Address complex bioanalytical challenges where increased analytical selectivity is needed

  • Support quantitative bioanalysis of biological analytes using advanced LC-MS workflows

  • Combine HRMS with low-flow chromatography for highly sensitive analytical approaches

  • Apply multiplexed analytical strategies when multiple analytes need to be monitored within a single method

What LC-MS services are available throughout drug development?

IQVIA Laboratories supports bioanalytical programs from early preclinical development through clinical development, Phase III and bioequivalence studies, with capabilities including assay development, method transfer, method validation and in-study sample analysis.

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