Complete Analytical Development Packages with mAb/ADC Harmonization

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Home 5 Service 5 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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