Advanced Characterisation of Biologics by High-Resolution Mass Spectrometry (HRMS)
We design and perform high-resolution mass spectrometry (HRMS) studies for the in-depth structural characterisation of biologic products, generating critical data for identity, variants, modifications, impurities, and comparability.
- Peptide mapping and variant characterisation
- Intact mass and subunit analysis
- Impurity and HCP profiling
- Comparability and change control support
HRMS enables the resolution of complex analytical questions through strategies focused on identifying structural variants, post-translational modifications, impurities, and other critical quality attributes in biological molecules.
Its application is particularly valuable when a high level of resolution is required to compare products, investigate analytical deviations, assess process changes, or deepen structural product characterisation.
We provide structural depth to strengthen comparability studies, variant investigations, and impurity identification in complex molecules that require advanced characterisation and robust analytical interpretation.
What Is HRMS Mass Spectrometry?
High-resolution mass spectrometry (HRMS) measures the mass of molecules with extremely high accuracy. It is essential in biologics development, where small variations may impact quality or safety, and it supports:
- Intact mass determination
- Identification of impurities and degradants
- Characterisation of structural modifications
- Sequence analysis
The Challenge of Biotherapeutic Characterisation
Modern biologic products present characteristics that can only be fully detected using high-resolution HRMS:
- High structural complexity
- Presence of critical impurities (shortmers, PTMs, degradation products)
- Batch-to-batch and process variability
- Need for in-depth characterisation for regulatory requirements
Our Solution: Orbitrap Exploris 240
Our LC-HRMS Orbitrap Exploris 240 system enables:
- High resolution and mass accuracy
- Detection of low-level impurities
- Detailed structural analysis
- Reproducible and traceable studies
What Does Our HRMS Mass Spectrometry Service Include?
1. Oligonucleotide Characterisation (Therapeutic DNA/RNA)
- Intact mass determination
- Charge profile analysis
- Identification of impurities (shortmers, longmers, degradation products)
- Sequence mapping
- Localisation of chemical modifications
Applications:
- Quality control of oligonucleotides (siRNA, ASO)
- Stability studies
- Process comparability
2. Peptide and Protein Analysis
- Peptide mapping
- Intact mass determination
- Identification of post-translational modifications (PTMs)
- Charge variant and subunit analysis
- Bioconjugate characterisation (ADCs)
Applications:
- Identity confirmation
- Sequence coverage
- Advanced structural characterisation
3. Quantitative Proteomics
Proteomics studies in complex biological matrices using:
- DDA (Data-Dependent Acquisition)
- DIA (Data-Independent Acquisition)
- PRM (Parallel Reaction Monitoring)
This enables:
- Protein identification and quantification
- Biomarker analysis
- Mechanism of action (MoA) studies
- Treatment response evaluation
HRMS Mass Spectrometry Technologies and Capabilities
- LC-HRMS Orbitrap Exploris 240
- High-coverage peptide mapping
- Intact mass analysis
- PTM identification
- Advanced quantitative proteomics
Regulatory Compliance
Our analyses follow full traceability, auditable methods, and comply with:
- European Medicines Agency
- U.S. Food and Drug Administration
- International Council for Harmonisation
- 21 CFR Part 11
Frequently Asked Questions (FAQ)
- What advantages does HRMS offer compared with other techniques?: It provides greater molecular mass accuracy and enables detection of impurities or modifications at very low levels.
- What are PTMs?: Post-translational modifications (PTMs) are chemical changes in proteins that may affect their function.
- Can therapeutic oligonucleotides be analysed?: Yes, including siRNA, ASO, and other complex oligonucleotides.
- What is peptide mapping?: It is a technique used to analyse protein sequences through digestion followed by mass spectrometry analysis.
- Are these studies suitable for regulatory submissions?: Yes, provided they are developed in accordance with European Medicines Agency, U.S. Food and Drug Administration, and International Council for Harmonisation guidelines.
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