Jianxin Guo

Reuniting the day’s presenters, don’t miss the final speaker panel discussion to ask any unanswered questions from the scientific presentations. With your fellow process, analytical, and CMC experts, break down the challenges and learnings across impurity qualification, charge variance characterization and comparability studies to best approach ADC regulatory submissions and understand the unique considerations in ADC CQAs from a small and large molecule perspective.

• Contextualizing CQA requirements from approved and marketed ADCs
• Breaking down CQA considerations across small molecule and biologic ADC components
• Supplementing CQA expectations with regulatory CMC guidance from available Health Authority published guidelines