Overview

We have worked on many conjugate projects across multiple biologic drug-conjugate technologies for some of the leading ADC product developers, including:

  • Antibody-Drug Conjugates
  • Protein-Drug Conjugates
  • Antibody-Peptide Drug Conjugates
  • Peptide-Drug Conjugates

Services for ADCs and other conjugated products include:

  • Drug-to-Antibody Ratio (DAR) Determination
  • Site Occupancy via Mass Spectrometry
  • Experience with Key Conjugation (Linker) Technologies
  • Analysis of Free Drug (Payload) and Naked Carrier Protein / Antibody
  • Confirmation of Secondary Structure and Aggregation (HOS)
  • Extensive Method Development and ICH Validation Capabilities
  • Methods for Quantifying Drug-Conjugate Components for PK and PD Studies
  • Mapping of PTMs, Disulfide Bonds and Glycosylation
  • cGMP Lot Release and Stability Testing
  • Reference Standard Characterization
  • Solubility Studies, Pre-formulation and Formulation Development
  • Forced Degradation Degradants, Impurities and Isoform Characterization
  • Bridging Studies and Comparability Programs