Skip to the main content.

Commercial Mass Spectrometry

Advanced Mass Spectrometry Analysis for Protein Characterization

Mass Spectrometry Analysis for Protein Characterization

State-of-the-Art Mass Spectrometry Core Facility to Support New Biologics


Mass spectrometry is among the most powerful analytical techniques available for protein characterization. KBI’s state-of-the-art mass spectrometry core facility delivers unparalleled structural characterization services to our clients.

Our expert team brings decades of experience in protein and peptide characterization to provide the right data with the right insight at all stages of development.

Whether you are seeking sequence verification and developability data to support proof-of-concept, initial structural characterization to support IND filing, or comprehensive impurity characterization to support BLA licensure, KBI will exceed your expectations.


Our Experience in Mass Spectrometry Characterization Includes:

  • Monoclonal antibodies (full-length mAbs, domain antibodies, antibody conjugates, fragments)
  • Fusion proteins
  • Multi-specific antibodies & proteins
  • Protein vaccines
  • Biosimilars, Biobetters, Biosuperiors
  • Other recombinant protein drugs
  • Proteomic work flows
    • Host Cell Proteins
  • Peptide drugs

Conquering Complexities with Advanced Mass Spectrometry

Expertise in Analytics

For Comprehensive Biotherapeutic Development, Manufacturing, and Downstream Processing

Expert Support for Development and Characterization at Every Phase of the Project Cycle

High-resolution mass spectrometry is a powerful tool used at KBI Biopharma for analytical strategies concerning complex samples. In support of biotherapeutics across the board, KBI's Mass Spectrometry Core Facility has championed the characterization and management of proteins, active pharmaceutical ingredients (APIs), and impurities through identification, characterization, assessment, and quantitation. At KBI, we are true partners working hand-in-hand with clients to conquer complexities and develop lasting solutions to the analytical challenges that come with the development of biologics.

  • High Selectivity
  • High Sensitivity
  • High Specificity
  • High Resolution
  • Backed by Decades of Experience

Conquer Complexities with Advanced Mass Spectrometry

MicrosoftTeams-image (69) Q&A with KBI's Mass Spectrometry Team

We recently sat down with Michael J. Nold, Ph.D., Senior Director of KBI’s Mass Spectrometry Core Facility in Durham, North Carolina, to discuss how advanced Mass Spectrometry plays a significant analytical role in the characterization and quantitation of APIs and impurities in complex biotherapeutics. 

Read the Q&A >>


MicrosoftTeams-image (70)

Using Advanced Mass Spectrometry for Characterization and Quantitation of APIs and Impurities in Complex Biotherapeutics

Advanced analytical capabilities, including mass spectrometry, are critical for the characterization of active pharmaceutical ingredients (APIs) and managing a diverse population of impurities. This allows for effective mitigation of safety risks and ensures product quality.  

Read the Article >>

KBI’s Mass Spectrometry Core Facility Capabilities

State-of-the-art Systems

  • Waters Acquity® UPLC – Sciex TripleTOF® 6600

  • Waters Acquity® UPLC – Xevo® G2 Q-Tof

  • Waters Acquity® UPLC – Xevo® G2-S Q-Tof

  • Waters Acquity® UPLC – Xevo® G2-XS Q-Tof

  • Synapt ® G2-Si High Definition Mass Spectrometer

Methods & Software


  • BiopharmaLynx™, Progenesis QI for proteomics, BioLynx®, ProteinPilot™, BioPharmaView™, MultiQuant™, MarkerView™, PeakView™


  • Intact mass analysis by RP-UPLC-UV/MS, determination of glycosylation patterns

  • Separation and characterization of deglycosylated and/or reduced mAbs and fusion proteins by RP-UPLC-UV/MS

  • Intact mass analysis by RP-UPLC-UV/MS of reduced and non-reduced subunits following IdeS treatment for hinge region cleavage

  • Heterodimer purity analysis by RP-UPLC-UV/MS


  • Peptide mapping mass spec by RP-UPLC-UV/MSE for sequence confirmation

  • Modification / degradation analysis including glycosylation; N-terminal pyroglutamic acid, pyroglutamine; C-terminal lysine truncation; deamidation; oxidation; etc.

  • N-terminal & C-terminal processing and sequence heterogeneity assessment and quantitation by RP-UPLC-UV/MSE

  • Sequence variant identification by RP-UPLC-UV/MSE

  • Targeted peptide verification by RP-UPLC-UV/MS/MS

  • Quantitative monitoring of peptides or post-translationally modified peptides under cGMP conditions

  • Disulfide mapping by RP-UPLC-UV/MSE

Glycan & Glycopeptide

  • RapiFluor labeled glycan identification and quantification of released N-glycans by HILIC UPLC-FLR/MSE

  • Glycan site occupancy from deglycosylated & reduced peptide map by RP-UPLC-UV/MSE

  • Site-specific glycan profiling of fully glycosylated & reduced peptide map by HILIC-UPLC-UV/MSE

Additional Mass Spectrometry Testing Services

  • Host cell protein analysis

    • ELISA support
    • Monitoring process clearance
    • Identification and relative quantitation
    • Targeted screening and quantitation
  • PEGylation site and occupancy analysis

  • Product and process-related impurity analysis

  • Cell line profiling

Ready to Learn More? Get in Touch with our Team.


Contact Us

Never Miss Another Update! 

Subscribe to KBI's Newsletter, The Pulse, to stay up-to-date on all the latest news, articles, and events from KBI Biopharma.