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Services & Solutions

Analytical Development


Analytical Development and Characterization of ADCs and other Bioconjugates

 

At WuXi XDC, we leverage in-house expertise and state-of-the-art analytical equipment to characterize the distinct intermediates (e.g., protein/mAb, payload and linker) and the bioconjugate including antibody drug conjugate (ADC) therapeutic candidates or diagnostic and imaging reagents at various stages of development. Methods utilized to assess and characterize these complex bioconjugated molecules include UV/VIS, HPLC, cIEF, LC-MS amongst others as is analytical assessment of drug-to-antibody ratio, free-drug content, ADC affinity, protein concentration, aggregation, pI, and peptide mapping. Methods utilized to assess and characterize these complex bioconjugated molecules include (but are not limited to):
 

HPLC

  • Drug-to-Antibody Ratio
  • Conjugation Efficiency
  • Aggregation
  • Free Drug Residue

MALS

  • Aggregation
  • Nanoparticle Characterization

LC-MS

  • Drug-to-Antibody Ratio
  • Conjugation Efficiency
  • Free Drug Residue
  • Peptide Mapping

Plate Reader

  • Ligand Binding/Affinity
  • In vitro Potency Test

Capillary Electrophoresis (CE) and Capillary Isoelectric Focusing (CIEF)

  • Non-Reduced & Reduced (CE-SDS)
  • Determination of pI (cIEF or iCIEF)

UV/Vis (NanoDrop and SoloVPE®)

  • Protein Concentration
  • Drug-to-Antibody Ratio

Additional Bioconjugate Characterization Capabilities:

  • Capillary Electrophoresis (Charge Heterogeneity and Product-related Impurities)
  • Native MS (Intact Molecular Weight Determination under Native Conditions)
  • Peptide Mapping (Conjugated Sites and Occupancy)
    Accurate Kd Determination
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