Antibody-Drug Conjugate Protein Content Detection Method

Antibody-drug conjugates (ADCs) are biologically developed therapeutic drugs formed by linking monoclonal antibodies with small molecule drugs using cross-linking agents. When discussing ADCs, one must mention the concept of drug-to-antibody ratio (DAR), which refers to the ratio of small molecule drugs to monoclonal antibodies in ADCs. It is a crucial quality attribute closely related to the efficacy and clearance rate of ADC drugs. Therefore, precise analysis is required during development and production. The ultimate goal of detecting protein content in ADCs is similar to conducting DAR analysis, which is to obtain the content or ratio of certain components in an ADC drug. Thus, the protein content can be calculated through the DAR value. Common methods for determining the DAR of ADC drugs include ultraviolet spectrophotometry, size exclusion chromatography, hydrophobic interaction chromatography, liquid chromatography-mass spectrometry, reversed-phase high-performance liquid chromatography, and hydrophilic interaction chromatography. The DAR value can reflect the relative content of monoclonal antibodies. If the content of small molecule drugs is known, the specific content of monoclonal antibodies in the ADC drug can be determined based on the DAR value.

Biotechnology company BiotaiPeike provides one-stop SEC analysis services for antibody-drug conjugates based on high-resolution mass spectrometry technology. We measure the structural characterization, drug efficacy, and drug impurities of ADCs to ensure comprehensive system analysis and evaluation of ADC structure and efficacy. Inquiries are welcome!

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