ServicesTranslational BiologyBiochemistryDevelopment Packages and TestingComplete Analytical Development Packages with mAb/ADC
Harmonization
Complete Analytical Development Packages with mAb/ADC
Harmonization
  • Concentration determination: spectrophotometry

  • Endotoxin level determination: LAL method

  • Drug to antibody ratio (DAR) determination: LC-MS, HPLC-HIC, RP-HPLC, etc.

  • Purity determination: SEC/ RP/ HIC-HPLC, SDS-PAGE, etc.

  • Residues of free drug determination: LC-MS/MS

  • Residues of solvent determination: GC

  • Site mapping determination: LC-MS

  • Sterility test: membrane filtration/direct inoculation


ADC Binding Properties

  • Biacore 8K

  • Octet Red

  • Biotek Plate Reader

  • FACS Canto II

Physiochemical Properties

  • Biomolecule/Linker-Payload Residue LC-MS

  • SEC/HIC/RP/CEX-HPLC

  • SDS-PAGE

  • CE-SDS/iCIEF


ADC Stability Studies

  • Uncle Protein Stability

DAR determination by multiple methodologies

LC-MS


HPLC-HIC


Reverse Phase-HPLC



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