“Antibody-drug conjugates (ADCs) unite the specificity of monoclonal antibodies with the potency of cytotoxic small molecules, promising stronger clinical responses and fewer systemic side effects. Turning that promise into a licensed medicine is, however, inherently risky: every reagent, process step and technology transfer can introduce impurities or shift critical quality attributes (CQAs) such as drug-antibody ratio (DAR), conjugation-site distribution and biological activity.”
Download our white paper ‘Analytical Risk Management in ADC Development: From Lab to Plant’ by Libin Zhu, Director of Analytical Research and Development at Veranova, to learn more about the practical framework for analytical risk management that links discovery labs, pilot facilities, and full-scale plants.
Grounded in quality-by-design principles, this white paper shows how systematic hazard analysis, impurity profiling and transparent data-sharing drive science-based specifications for starting materials, intermediates and finished product. Libin reviews current best practice and explain how to weave these tools into a lifecycle management plan that adapts as the process matures.
By integrating rigorous impurity control, fit-for-purpose specifications and seamless collaboration between analytical, process and regulatory teams, the approach outlined here provides a blueprint for delivering consistent, safe and commercially viable ADCs.
