for IND filing & BLA licensure
sequence verification & developability data
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:
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
UPLC-UV/MS, UPLC-UV/MS/MS, UPLC-UV/MSE, UPLC-FLR/MSE, UPLC‑UV/SWATH
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 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
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
Host cell protein analysis
PEGylation site and occupancy analysis
Product and process related impurity analysis
Cell line profiling