Drug to Antibody Ratio (DAR) Analysis

Antibody-drug conjugates (ADC) are a new class of biological therapies that combine drugs with monoclonal antibodies to provide targeted delivery. They are designed to deliver potent cytotoxins to tumors, thereby minimizing systemic toxicity. The drug-antibody ratio (DAR) of ADC has an important impact on the efficacy and pharmacokinetics of ADC. Drug-antibody ratio (DAR) refers to the average number of drugs combined with antibodies. Low drug loading will reduce the efficacy, while high drug loading will have a negative impact on pharmacokinetics and toxicity. Therefore, optimization and close monitoring of DAR during ADC development is also important because it provides a reliable solution for the determination of DAR in ADC in pharmacokinetics.

Figure 1. Te synthesis of lysine-linked ADCs, dual-payload ADC, and glycosite-specifc ADC¹.

As a reliable third-party testing company in the biopharmaceutical industry, Alfa Chemistry has advanced technology platforms and knowledgeable scientists to provide comprehensive and high-quality DAR analysis to customers around the world. Our experts are well aware of the importance of DAR in pharmaceutical development and have extensive experience and expertise in the analysis of new biotherapies, so we can provide you with technical support for testing at all stages of drug development. For more information on drug to antibody ratio analysis, please feel free to contact us.

Alfa Chemistry's DAR analysis includes but not limited to:

• Confirmation of secondary structure and polymerization

• Solubility detection

• Structural stability testing

• Identification of post-translational modification and binding sites

• Verification of validity of the conjugate

Alfa Chemistry's technology platforms include but not limited to:

• Ultraviolet-Visible (UV/Vis) Spectroscopy

• Enzyme Linked Immunosorbent Assay (ELISA)

• Two-dimensional Difference Gel Electrophoresis (2-D DIGE)

• Hydrophobic Interaction Chromatography (HIC)

• Reversed Phase High-performance Liquid Chromatography (RP-HPLC)

• Fourier Transform Ion Cyclotron Resonance-Mass Spectrometry (FTICR-MS)

• MALDI-TOF-MS

• ESI-QTOF-MS

• LC-MS/MS

Alfa Chemistry's advantages:

Reference

• Yubo Tang. (2017). 'Real-Time Analysis on Drug-Antibody Ratio of Antibody-Drug Conjugates for Synthesis, Process Optimization, and Quality Control.' Nature. Scientific Reportsvolume 7, Article number: 7763.