Mass spectrometry
Mass spectrometry (MS) is one of the most versatile and insightful analytical tools in pharmaceutical development. At Quality Assistance, mass spectrometry isn’t just a technique, it is a core capability integrated into every aspect of our analytical service offer.
We use MS daily to help you uncover what lies behind your drug candidate, from its in-depth molecular characterisation, including isoforms and impurities, to the precise quantification of active substances in complex biological matrices.
Where we apply Mass Spectrometry
Our MS platform supports a wide range of molecules and analytical challenges. Whether you need structural confirmation, quantitative bioanalysis or impurity profiling (including nitrosamine risk assessment), we tailor our approach to fit your development stage and regulatory context. Our experts develop and validate methods that deliver the performance and regulatory compliance your project demands.
- Recombinant proteins, monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs)
- mRNA and other RNA-based therapeutics
- Adeno-associated viruses (AAVs) and other viral vectors
- Peptides and oligonucleotides
- New Chemical Entities (NCEs)
- Vaccines
Therapeutic modalities we cover
Our Mass Spectrometry Platform
Our integrated laboratory is equipped with innovative and advanced platforms and technologies giving you the confidence and data you need for your product development:
- Q-ToF for high-resolution mass characterisation of complex biomolecules, impurity profiling and PTMs analysis
- MALDI-TOF/TOF for rapid mass fingerprinting of highly glycosylated proteins, pegylated peptides/proteins and glycans
- 2D-UPLC system for enhanced resolution of closely related species and product heterogeneity analysis
- ICP-MS for elemental impurity profiling (ICH Q3D compliance)
- Single Quadrupole (SQ) and Triple Quadrupole (TQ) for targeted bioanalytical quantification
- GC-MS for residual solvents and volatile impurity analysis
- HDX/MS platform for higher-order structure analysis and molecular interaction characterisation (epitope mapping) (non-GMP)
Mass spectrometry is one of the key technologies we integrate into broader characterisation strategies. Explore our product characterisation services page to see how MS, combined with orthogonal analytical methods, delivers a complete regulatory-ready profile of your molecule.
Related services
Regulatory-ready expertise
All our MS workflows are:
- Compliant with EMA, FDA, and ICH guidelines.
- Tailored to your specific development phase and molecule modality.
- Supported by scientific experts with over 20 years of hands-on MS experience.
We also offer pre-developed, off-the-shelf MS workflows that can be deployed upon request and can be optimised for your specific molecule as needed.
Accelerating tomorrow’s medicines through analytical excellence
Mass spectrometry is more than a technique, it’s the analytical core that supports clarity, compliance and confident decision-making. At Quality Assistance, we help you turn complex analytical questions into actionable insights, every step of the way.