Analytical Characterization

NovaBioAssays provides the LC-MS or LC-MS/MS based analytical characterization services for Antibody-Drug Conjugates (ADCs) and other therapeutic proteins, such as bispecific antibodies, Fc fusion proteins, antibody fragments (Fab, Fc, and Nanobodies), etc. We provide a suite of biophysical, chromatography and mass spectrometry methods to characterize aggregation, charge variants, purity, sequence, clipping/PTM and glycosylation for the analyte protein. Selected services are:
  • SEC-UV, SEC-MALS, and native SEC-MS
  • IEX-UV, native IEX-MS, and iCIEF-UV for charge variant
  • HIC-UV for hydrophobic variant
  • Intact Molecular Weight Determination
  • Peptide Mapping
  • Post Translational Modification(PTM) Analysis
  • Disulfide Bridge Mapping
  • Glycosylation Analysis and Glycosylation Site Mapping/Occupancy Determination
  • Protein Identification

In addition to the assays characterizing regular therapeutic proteins,  we provide following services for ADC:
  • Drug-to-Antibody Ratio (DAR) Determination (example shown in figure below) 
  • Site Occupancy
  • Linkage site identification
  • Analysis of Free Drug (Payload) and Naked Carrier Protein/Antibody
  • Quantification of Drug-Conjugate Components