Metabolomics / Non-GLP

Untargeted and targeted quantitative metabolomics services for biomarker discovery, pharmacodynamic characterization, and mechanistic research.

Metabolomics provides a comprehensive view of the biochemical consequences of disease, pharmacological intervention, and physiological perturbation. By profiling the full complement of small-molecule metabolites in biological samples—including amino acids, lipids, organic acids, nucleotides, and a wide range of other biochemical species—metabolomics delivers insights that cannot be achieved through genomic or proteomic approaches alone.

AMSbiopharma offers complementary untargeted and targeted quantitative metabolomics services, enabling sponsors to progress seamlessly from biomarker discovery to validated quantitative assays suitable for clinical development and regulatory submissions.

All metabolomics studies are performed under controlled analytical conditions within a rigorous quality management framework, ensuring data reproducibility across analytical batches and study time points.

Our catalog of services include

Untargeted Metabolomics (Relative Quantification)

Untargeted metabolomics enables the simultaneous, unbiased profiling of hundreds of metabolites across multiple biochemical classes in a single analytical run, without prior selection of target analytes. This approach is particularly valuable during the discovery phase, where metabolic profiling data can reveal altered metabolic pathways and identify potential biomarker candidates for further investigation.

AMSbiopharma employs high-resolution mass spectrometry (HRMS) platforms operating in both positive and negative ionisation modes, combined with advanced data processing workflows for peak detection, alignment, normalisation, and metabolite annotation against reference databases. Statistical analyses are performed to identify significantly altered metabolites and metabolic pathways across study groups.

All analytical runs include a comprehensive set of quality control (QC) samples and reference standards to continuously monitor analytical performance and ensure the generation of reliable, high-quality data.

Key analytical capabilities

HRMS-based metabolic profiling in positive and negative ionisation modes
Simultaneous detection of hundreds of metabolites across multiple biochemical classes
Database-driven metabolite annotation and metabolic pathway mapping
Comprehensive quality control strategy to ensure data quality and analytical robustness
Applicable to plasma, urine, and tissue samples

Targeted Quantitative Metabolomics

Targeted quantitative metabolomics provides accurate, validated quantification of defined metabolite panels, delivering the data quality required for clinical biomarker programmes, pharmacodynamic monitoring studies, and regulatory submissions.

AMSbiopharma offers targeted quantitative metabolomics services using validated LC-MS/MS methods for the simultaneous quantification of predefined metabolite panels. Method development and validation are performed in accordance with applicable regulatory guidelines, covering sensitivity, specificity, linearity, accuracy, precision, and stability.

Our metabolite panels cover the major metabolic pathways—including amino acid, lipid, energy, nucleotide, and one-carbon metabolism—with the flexibility to design custom panels tailored to specific programme requirements.