Characterization studies

Product characterization

  • In-depth drug substance & product characterization with a broad suite of analytical techniques, including but not limited to
    • High resolution mass spectrometry (LC-HRMS)
      • Biomolecule characterization (e.g. mAbs, ADC, oligo's):
        Intact mass - Subunit analysis, peptide mapping, glycan profiling, post-translational modifications (PTMs)
      • Trace impurity testing, including nitrosamines.
      • Host-cell protein (HCP) analysis
      • And many more applications.
    • Chromatography (HPLC/UPLC)
      • API quantification, impurity profiling, forced degradation, aggregation, and more. 
    • Spectroscopy
      • Physicochemical characterization, identification, concentration, and more.
    • (Capillary) gel electrophoresis
      • Purity assessment, charge variants, and more.
  • High-quality, reproducible data to support CMC strategy and regulatory submission.
  • Expert scientific interpretation to de-risk development decisions and accelerate program timelines.

Meet our scientists

 

Explore our application notes and posters on HRMS

- Comprehensive monoclonal antibody characterization

- Antibody-drug conjugate characterization

- Forced degradation study

- Multi-attribute workflow for ADC characterization

- Stability modeling and shelf-life prediction of lipid-modified oligonucleotides

Our end-to-end analytical solutions for drug development

Get in touch with our team