ADC Analysis
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ADC Analysis

Creative BioMart Chromatography provides one-stop ADC analysis services to help you solve the problems and challenges in the drug development process. The antibody-drug conjugate (ADC) is a combination of the high specificity of monoclonal antibody drugs and the high activity of small molecule cytotoxic drugs to improve the targeting of tumor drugs and reduce toxic and side effects. ADC usually consists of a fully-humanized monoclonal antibody (mAb), a cytotoxic drug, a suitable linker, and an antigen expressed specifically on tumor cells (Fig. 1). This structure maintains the cytotoxicity, targeting and stability of ADC in the systemic circulation. The right combination is the key to develop ADC successfully. Due to the complex structure of ADC drugs, there are great differences among different ADC drug designs. Even different drugs at the same target have significant differences in toxicity due to different recognition sites, connection sites, and small molecules attached. Moreover, the drug-to-antibody ratio (DAR) is one of the important parameters for evaluating ADCs drug production process and product quality. Therefore, a comprehensive analysis of ADC drug structure, DAR, efficacy, and safety is extremely necessary. Our solutions include but are not limited to hydrophobic interaction chromatography (HIC), SEC, liquid chromatography-mass spectrometry (LC-MS), UPLC, reversed phase HPLC (RP-HPLC), ESI-TOF mass spectrometry, MALDI-TOF mass spectrometry, UV/Vis spectrum, etc.

Structure and mechanism of action of ADCFig. 1 Structure and mechanism of action of ADC. (Tsuchikama, K.; An, Z. Q., 2016)

ADC Analysis Techniques

  • Hydrophobic Interaction Chromatography (HIC): HIC is the primary method used for quality assessment and reaction monitoring, which can be used for analyzing ADCs with acid-labile linkers due to the mild nature of the separation process. It must be initially paired with mass spectrometry analysis to determine peak identity or DAR.
  • Liquid Chromatography-Mass Spectrometry (LC-MS): A LC-MS analysis of ADC can be performed to calculate DAR, and to ensure that the conjugation is complete within the suggested time frame.
  • Ultraviolet-Visible (UV/Vis) Spectrum: UV/Vis spectrum is the simplest and most convenient approach for DAR determination. If species of different DAR are separated using a salt gradient and detected by UV spectrum that absorbance at 280 nm. The average DAR and distribution profile is determined by the peak area percentage of each species.

Our Specialty

  • The technical team is experienced in testing and arranges the experiments in a timely and rigorous manner.
  • Standard calibration of testing equipment on time to ensure accurate and reliable test data.
  • Professionals analyze test data and assist in solving technical problems effectively.
  • Perfect and thoughtful pre-sales and after-sales service, and timely solve customers' questions.

Creative BioMart Chromatography has a variety of advanced chromatography and mass spectrometry instruments, combined with a professional analysis team, can quickly and accurately provide customer with top-quality ADC analysis services. We also provide custom services to meet the customer’s special needs. Our customers have direct access to our experts and give timely feedback to any online inquiries. If you are interested in our services, please contact us.

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Reference:

  1. Tsuchikama, K.; An, Z. Q. (2016). Antibody-drug conjugates: recent advances in conjugation and linker chemistries. Protein & Cell. 9. 10.1007/s13238-016-0323-0.
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