Liquid chromatography-tandem mass spectrometry (LC-MS/MS) separates the compounds in a sample by liquid chromatography and then identifies and measures them by mass, which gives sensitive, selective, and accurate quantification. Developers use it to measure drugs, metabolites, peptides, proteins, lipids, and biomarkers in biological samples, and to characterize drug substances and biotherapeutics. Our LC-MS/MS services provide highly sensitive and accurate analytical solutions for drug development, biomarker discovery, and biologics characterization.

Bioanalysis of small molecules for PK/PD, toxicokinetic, and bioavailability studies; metabolite profiling and identification, including ADME and human liver microsome studies; targeted proteomics for biomarker verification; biotherapeutic and peptide quantification, including peptide mapping, PTM analysis, degradation profiling, and biosimilarity assessment; untargeted and targeted lipidomics and metabolomics; and toxicology and reactive intermediate screening.

We use SCIEX triple quadrupole and TripleTOF mass spectrometry platforms, including the QTRAP 6500+, a hybrid triple quadrupole/linear ion trap system, and the TripleTOF 6600, a high-resolution quadrupole time-of-flight (QTOF) system.

We develop and validate LC-MS/MS methods for small molecule bioanalysis in support of PK/PD, toxicokinetic, and bioavailability studies, and we use high-throughput LC-MS analysis when programs need it. We also profile and identify metabolites, including ADME and human liver microsome studies, and screen for reactive intermediates as part of toxicology support.

Small molecules, peptides, proteins, metabolites, lipids, and biomarkers, including biotherapeutics such as monoclonal antibodies and antibody-drug conjugates (ADCs). Small molecule assays are run in plasma, urine, and tissue, and targeted proteomics is run in biological matrices.

We use LC-MS/MS for biotherapeutic and peptide analysis, including peptide mapping, post-translational modification (PTM) analysis, degradation profiling, and biosimilarity assessment, across monoclonal antibodies, ADCs, peptides, and proteins.

We offer targeted proteomics for biomarker verification, plus untargeted and targeted lipidomics and metabolomics for biomarker discovery, using LC-MS/MS platforms with high sensitivity and selectivity.

For drug concentration assays in nonclinical and clinical studies, the governing guideline is ICH M10, Bioanalytical Method Validation and Study Sample Analysis (ICH Step 4 in May 2022; FDA’s final version dated November 2022). It covers chromatographic and ligand-binding assays for chemical and biological drugs and their metabolites, and it excludes biomarker bioanalysis and immunogenicity assays. We design and validate methods for these studies to its recommendations, so the data are ready to support regulatory submissions.

We provide CGMP- and GLP-compliant services in a 21 CFR Part 11-compliant environment; the facility is FDA-inspected and CLIA-registered. Our CMC support includes method development and validation, impurity profiling, stability studies, drug substance characterization, excipient and residual solvent quantification, and release testing.

It depends on specificity, reagent availability, and what the study needs. LC-MS/MS offers high specificity, multi-analyte detection, and metabolite profiling, and it depends less on custom critical reagents; ligand-binding assays can be more sensitive for large molecules but depend on capture reagents that may lack specificity. A hybrid assay adds immunoaffinity capture before LC-MS/MS detection when immunoassay selectivity is a limit. For proteins and antibodies, LC-MS/MS quantification is often done on surrogate peptides generated by digestion. We recommend the approach after a feasibility look at your molecule.

Plasma, urine, and tissue for small molecule assays and biological matrices for targeted proteomics. We build the method around the matrix your study will collect, because matrix effects can suppress or enhance ionization and have to be assessed in each matrix.

Sensitivity is set per analyte and matrix during method development, because the lower limit of quantitation depends on the compound’s ionization, the sample cleanup, the volume you can collect, and the range your study needs. We establish and document the LLOQ in validation instead of quoting a single number that may not apply to your molecule, and we’ll tell you up front how much sample each assay needs.

As early as your analyte and study design are defined. The most useful starting information is the analyte and its type (small molecule, peptide, antibody, ADC), the matrix and species, the study type (PK/TK, biomarker, characterization, release), the concentration range you expect, the quality level you need (research, GLP, CGMP), and any method or reference standard you already have. Choosing the guidance framework and validation scope once, up front, avoids re-running early work later to make it comparable with what the program eventually needs.