Comparison of the Stability Across an Antibody Drug Conjugate Platform In Vivo by Monitoring Changes in Average Drug-to-Antibody Ratio Using Affinity Capture LC-MS

摘要

The affinity capture LC-MS method has been successfully used to obtain the drug-to-antibody ratio (DAR) distributions of TDCs in plasma both in vitro and in vivo. Results indicated that site of conjugation could have significant impact on the TDC stability. Stability of TDCs can be quantitatively compared across different conjugation platforms by measuring the changes in average DAR of TDCs over time. Accurate evaluation of the TDC stability can enable better decision making in drug development.