Lara Fernandez-Cerezo

• Sharing feedback from a recent meeting with the FDA on ADC control strategies including regulatory starting materials, impurity control, release testing, and comparability
• Assessing drug-linker attributes in the context of the ADC drug product and its utility in establishing specifications, impurity control strategies, and comparability approaches
• Discussing industry experiences with post-approval changes to drug-linker processes and a framework for managing such changes

The complex synthesis process of drug-linker manufacturing and conjugation stages opens the door for ADC impurities that are difficult to identify and control and demonstrate confidence to regulatory bodies

Join this workshop led by big pharma leaders and members of the IQ consortium to investigate the playbook for ADC impurity process and control strategy.