Elizabeth A. Martin

A Science-Based Proposal for the Identification Threshold of Organic Impurities in Drug–Linker Intermediates Used to Produce Antibody–Drug Conjugates

Abstract The identification threshold for organic impurities in drug–linker (D–L) intermediates used to manufacture antibody–drug conjugates (ADCs) remains undefined in the current regulatory landscape. Building on our previously established 1.0% w/w qualification threshold, we propose a science-based identification th...