オーラルセッション
- 第2日 5月20日（木） 10:20～10:40 B会場（Zoom）
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2B-O7-1020 PDF
質量分析による抗体薬物複合体の特性解析
In the biopharmaceutical field, antibody-drug conjugate (ADC) is gathering attention because of its efficacy and safety. However, most of the conventional ADCs have been produced by random conjugation, so there are some remaining room for the improvements of efficacy, safety and regulatory science. To resolve these problems, we developed the AJICAP® technology. AJICAP® is a method of affinity peptide mediated regiodivergent functionalization that enables the manufacturing of site-specific ADCs from native IgG antibodies. We conducted characterization analysis by using mass spectrometry, such as intact protein analysis, middle-up analysis and peptide mapping analysis to demonstrate the site-specificity of the AJICAP®-ADC. By the intact protein analysis, the average drug-to-antibody ratio (DAR) was calculated as 2. Regarding the middle-up analysis, reduced ADC was analyzed and revealed that the drug specifically conjugated with heavy chain of the antibody. Finally, tryptic digestive was submitted for the peptide mapping analysis. Consequently, the drug conjugation site was identified as the specific Lys residue on the heavy chain. From these results, we concluded that AJICAP® method has the ability of producing site-specific ADCs. In this presentation, we will introduce the issues and considerations about these analyses.