This white paper explores the critical analytical challenges in ADC development, focusing on characterization, stability and potency of each ADC component and the need for comprehensive analytical strategies.
Characterizing Each Component
Antibody integrity, linker stability and payload potency each require dedicated analytical methods and control strategies.
Drug-to-Antibody Ratio
DAR distribution drives safety and efficacy. HIC, LC-MS and related techniques provide the resolution needed for control.
Stability and Potency
Stability-indicating methods and cell-based potency assays ensure consistency from development through commercial release.
About This White Paper
This white paper is published by Solvias and curated by Biotechnology Media Insights, a trusted source for pharmaceutical and biotechnology research, technical guides and industry analysis.