ADC Analysis and Characterization

ADC Analysis and Characterization

BOC Sciences is responsible for ADC quality research including ADC drug identification, specification, content, purity, safety and quality analysis and method development, validation and testing. Antibody-Drug Conjugates (ADCs) are a new class of biopharmaceuticals made by coupling monoclonal antibodies and small-molecule drugs with strong cytotoxicity through biologically active linkers. The following problems arise during the preparation of commonly used antibody-conjugated drugs:

  • Some antibodies cannot be successfully coupled with small-molecule drugs.
  • There are multiple binding sites (Cys, Lys residues, etc.) in the antibody, and the difference of binding sites and binding amount will lead to heterogeneity.
  • Due to the higher hydrophobicity of small molecule drugs, the difference of binding amount with monoclonal antibodies may lead to the change of hydrophobicity of ADC drugs.

The heterogeneity of these unconjugated naked antibodies and small molecules with cytotoxicity as well as the coupling drug may affect the efficacy and safety of ADC drugs. Compared with monoclonal antibodies, the production process of ADCs drugs is more complicated. Therefore, in order to ensure the safety and effectiveness of ADCs drugs, the quality of ADCs drugs needs to be monitored. Drug to antibody ratio (hereinafter referred to as DAR) is one of the important parameters for evaluating ADCs drug production process and product quality. Therefore, a comprehensive evaluation of ADC drug structure, DAR, efficacy, and safety is essential before ADC filing. BOC Sciences has a variety of advanced chromatography and mass spectrometry instruments, combined with a professional bioinformatics analysis team, can quickly and accurately provide you with a professional system of antibody-conjugated drug analysis and evaluation services.

BOC Sciences provides a one-stop system for the analysis and determination of antibody-conjugated drugs. The service project is divided into three modules, which respectively measure the structural characterization, drug effect, and drug impurities of antibody-conjugated drugs, and ensure a comprehensive system analysis and evaluation of ADC structures and drug effects. In the technical report, BOC Sciences will provide you with a detailed technical report, the report includes:

  • Experimental steps
  • Related MS parameters
  • The original data
  • ADCs analysis results

The target analytes that BOC Sciences can provide include

  • Antibody in total
  • Conjugated antiboy
  • Unloaded antibody
  • Conjugated drug
  • Free/dissociated drug
  • Metabolites

The non-clinical PK study that BOC Sciences can provide include

  • Serum stability assays
  • In vitro metabolites analysis
  • ADC drug release assays
  • Safty evaluation
  • Distribution study

The DAR analysis that BOC Sciences can provide include

  • DAR analyzed by LC/MS
  • DAR profile by HIC-UV
  • mAb/ADC concentration by ELISA
  • Free drug by MS

mAb Release and Characterization Testing mAb Release and Characterization Testing

Detection platform owned by BOC Sciences

  • MALDI-TOF mass spectrometry
  • ESI-TOF mass spectrometry
  • UV/VIS spectrum
  • UV-MALDI mass spectrometry
  • Reversed-phase high-performance liquid chromatography (RP-HPLC)
  • Hydrophilic Interaction Chromatography (HILIC)
  • Ion exchange chromatography (IEX)
  • Hydrophobic Interaction Chromatography (HIC)
  • Size Exclusion Columns (SEC)

ADC Characterization ADC Characterization


  1. Wagh, A. et al. Challenges and new frontiers in analytical characterization of antibody-drug conjugates. MAbs. 2018;10(2):222-243.
  2. Wakankar,A. et al. Analytical methods for physicochemical characterization of antibody drug conjugates. MAbs, 2011; 3(2):161-172.
* Only for research. Not suitable for any diagnostic or therapeutic use.

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