Antibody-Drug & Other Conjugates

Charles River provides a broad array of analytical services designed to deliver a complete set of analytical solutions for antibody-drug conjugate (ADC) development and testing. We have worked on many conjugate projects across multiple biologic drug-conjugate technologies for some of the leading ADC product developers, including:

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

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Biophysical Characterization

With a portfolio of assays to examine higher-order structure, Charles River can help clients complete their product characterization programs.

Preclinical Support for ADCs

This technical sheet details how Charles River can address your preclinical need for antibody-drug conjugates.

ADC Characterization by LC-MS/MS

This poster describes LC-MS/(MS) approaches addressing various ADC attributes, including drug-antibody ratio (DAR) determination, mapping of drug conjugation sites, and accounting for various drug/linker chemistries.