Bioanalysis Zone

Application note: Development of integrated informatics workflows for the automated assessment of comparability for antibody-drug conjugates (ADCs) using LC-UV and LC-UV/MS (Waters Corporation)

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In this application note, we demonstrate the use of an integrated informatics workflow in UNIFI Software that streamlines data acquisition, processing and reporting for ADC analysis by LC-UV or LC-MS, so that information from multiple analytical techniques can be effectively integrated for rapid and quantitative assessment of the comparability of ADCs.

Drug to antiboty (DAR) values and drug loading distributions for cysteine-conjugated ADCs are automatically acquired from HIC LC-UV analysis and from native SEC LC-MS analysis, and the results show excellent agreement between these two methods. The workflow automatically produces DARs and drug loading distributions for lysine-conjugated ADCs from RP LC-MS analysis.

This automated workflow removes the necessity of manual data processing and reduces the associated human errors. The workflows in UNIFI can be saved and shared, enabling consistent high-quality data generation, processing, and reporting for complex ADC datasets with an unparalleled capability to aggregate and manage data.

Collectively, we believe this integrated informatics workflow will be an enabling tool for organizations working in the discovery or development of ADC biotherapeutics, providing increased confidence in results, productivity, and financial gains.

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