Metabolite Identification and Untargeted Metabolomics for Drug Development
Emery Pharma provides advanced analytical capabilities for metabolite identification and untargeted metabolomics across complex biological matrices. These services support drug discovery and development by delivering insight into metabolic pathways, structural characterization, biomarker discovery, and broader biological response.
Using platforms such as NMR, LC-HRMS, GC-MS, and LC-MS/MS, our team generates high-quality data aligned with regulatory expectations to support safety assessments, IND-enabling work, and early development decision-making.
Core Qualitative Bioanalysis Capabilities
Emery Pharma’s qualitative bioanalysis capabilities are centered on two complementary areas: metabolite identification and untargeted metabolomics. Together, these services help clients understand drug biotransformation, investigate safety-related metabolic pathways, and uncover broader biological insights from complex samples.
Metabolite Identification and Characterization (MetID)
Description
MetID focuses on the qualitative identification and structural characterization of drug metabolites in biological matrices. This service provides critical insight into drug metabolism, supporting metabolite profiling studies and safety evaluations.
Methodology
Emery Pharma utilizes advanced analytical platforms including NMR, LC-HRMS, GC-MS, and LC-MS/MS to perform drug metabolite structural characterization. Studies are conducted in alignment with FDA/EMA guidance, with GLP compliance applied where required, ensuring data integrity for regulatory submissions.
Deliverables
- Comprehensive metabolite identification reports
- Structural characterization data and interpretation
- Supporting documentation for IND submission packages
- High-quality analytical datasets compliant with regulatory expectations
Untargeted Metabolomics Analysis
Description
Untargeted metabolomics provides qualitative mapping of metabolites across complex biological systems, enabling global metabolite profiling and untargeted biomarker discovery. This approach is ideal for uncovering novel biological insights and disease mechanisms.
Methodology
Using NMR, LC-HRMS, GC-MS, and LC-MS/MS platforms, Emery Pharma conducts untargeted metabolomics testing. Our advanced analytical workflows enable comprehensive metabolite detection and robust metabolite mapping services across diverse sample types.
Deliverables
- Global metabolite profiling datasets
- Biomarker discovery reports
- Technical reports suitable for research and regulatory use
Discuss Your Qualitative Bioanalysis Needs
Our Scientists
Prajita Pandey, Ph.D. is an analytical chemist and Associate Director at Emery Pharma, where she directs advanced method development and validation strategies for pharmaceutical products. With extensive experience in the structural characterization of complex large molecules, Dr. Pandey advises on the critical quality attributes of monoclonal antibodies, ADCs, and peptides. She ensures that analytical workflows align with ICH and FDA guidance, supporting reliable structural characterization and metabolite identification efforts required for drug development programs. Dr. Pandey’s background makes her well aligned to support metabolite identification (MetID) and untargeted metabolomics studies requiring high-confidence qualitative analysis.
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Applicable Standards
FDA/EMA guidance; GLP where applicable
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Target Product / Molecule Type
Small Molecules, Peptides, Biologics, Metabolites
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Sample Requirements
Variable, depending on analyte
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Key Applications
Metabolic pathway elucidation, Safety pharmacology support, IND submission package, Biomarker discovery, Disease mechanism insights
Why Choose Emery Pharma for Qualitative Bioanalysis
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GLP/GMP Compliance
Our qualitative bioanalysis workflows are conducted under GLP conditions where applicable, ensuring that metabolite identification assays and metabolomics studies meet stringent regulatory expectations for safety and submission readiness. -
Regulatory Expertise
We align MetID studies with FDA/EMA guidance, helping clients generate data that supports IND submissions and reduces regulatory risk.
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Breadth of Instrumentation and Methodologies
Our access to NMR, LC-HRMS, GC-MS, and LC-MS/MS enables comprehensive metabolic analysis and global metabolite profiling, delivering high-resolution insights across diverse molecule types. -
Rapid Turnaround Times
Efficient workflows and experienced scientific teams enable timely execution of metabolite identification testing and metabolomics studies, supporting fast-paced discovery and preclinical timelines. -
Cross-Industry Experience
With deep expertise across pharmaceutical and biotechnology sectors, Emery Pharma supports a wide range of applications—from drug-drug interaction risk assessment to untargeted biomarker discovery—ensuring relevance across multiple therapeutic and research areas.
State-of-the-art instruments used in qualitative bioanalysis. Top left: LC-HRMS LC-MS/MS, top right: NMR, Bottom: LC-MS
Request MetID or Untargeted Metabolomics Services
Frequently Asked Qualitative Bioanalysis Questions
What is qualitative bioanalysis?
Qualitative bioanalysis focuses on identifying and characterizing compounds—such as drug metabolites—within biological matrices. It provides critical insights into metabolic pathways, safety profiles, and biological activity during drug development.