Product characterisation

Characterising your molecule is more than just a regulatory obligation, it’s the strategic foundation that empowers you to make confident decisions at every step of your drug's development. At Quality Assistance, we go beyond standard analysis to provide high-resolution, multi-technique characterisation specifically tailored for your most complex molecules.

Our approach involves designing and executing a coordinated, multi-approach strategy to understand every Quality Attribute of your drug candidate. From molecular identity to higher-order structure and batch comparability or biosimilarity assessment, we build a complete and reliable analytical profile of your product, with the precision, speed and full GxP compliance you depend on.

While High-Resolution Mass Spectrometry (HRMS) plays a central role, it is integrated within a broader analytical framework combining orthogonal techniques for a comprehensive understanding of your molecule.

We support you from early development through batch release testing, ensuring the data you generate is submission-ready.

What we characterise

Each product is unique, and so is our approach. Our scientific teams design your characterisation plan based on your molecule, regulatory constraints, and development phase. High-Resolution Mass Spectrometry (HRMS) is a cornerstone of our analytical strategy. It enables precise and sensitive characterisation across a wide range of modalities, including:

  • Proteins, mAbs and ADCs

    • Intact mass analysis
    • Subunit analysis
    • Peptide mapping (MS/MS sequencing)
    • PTMs and Multi-Attribute Methods (MAM)
    • N- and O- Glycosylation profiling
    • DAR and drug-load distribution
    • Isoform / Impurity identification (incl. icIEF charge variants)

  • mRNA

    • Oligonucleotide mapping
    • Capping efficiency determination
    • PolyA tail profiling (size and distribution)

  • AAV

    • Identity of VP proteins at the intact level
    • Identity by peptide mapping, including PTMs

  • Peptides

    • Identity and impurity profiling (MS/MS)

  • Oligonucleotides

    • Degradation profiling
    • Sequence confirmation

  • NCE

    • Impurity identification and quantification
    • Structure elucidation

Therapeutic modalities we cover

Our platforms and technologies at your service

Our GMP-qualified facility is equipped with innovative and advanced platforms and technologies. We combine orthogonal techniques to give you a complete understanding of your molecule:

  • Mass spectrometry (MS): HRMS for intact mass, mapping and PTM characterisation
  • Chromatography: (U)HPLC and 2D-LC
  • Electrophoresis: icIEF and CE-SDS for charge / size variants, isoforms and purity profiling
  • Light Scattering: DLS and MALS (hyphenated to SEC or AF4) for size distribution and aggregation analysis
  • Structural Analysis: Circular Dichroism (near/Far-UV CD) and FTIR for secondary and tertiary structure and stability assessment
  • Elemental profiling: ICP-MS for elemental impurity support
  • Biomolecular Interaction Analysis: SPR (Surface Plasmon Resonance, Biacore) and BLI (BioLayer Interferometry, Octet) for binding characterisation, including affinity, kinetics, and specificity

See our dedicated pages for more details

Mass spectrometry

Elemental impurities

Regulatory-ready expertise

All our characterisation workflows, supporting comparability assessment, are:

  • Fully documented and transferable to GxP environments (GMP, GLP, GcLP/GCP)
  • Aligned with EMA, FDA, ICH, USP and Ph. Eur. guidelines
  • Adapted to your molecule’s development phase and needs
  • Supported by highly qualified scientists and experts

Accelerating tomorrow’s medicines through analytical excellence

With characterisation at the core of development success, you need a partner who understands both the science and the regulatory landscape. Quality Assistance transforms complexity into clarity, empowering you to bring life-changing therapies to patients with confidence and speed.

Let’s design your characterisation strategy together.

Contact our experts

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