Constructing a Compelling CMC Narrative for ADC Approval Transform Complex Analytical Data into a Coherent Story of Product Understanding & Control
- Structure the analytical sections to tell a compelling story of product understanding and control, going beyond simply presenting data to demonstrating a state of control, increasing reviewer confidence and facilitating a smoother BLA approval process
- Choosing characterization and comparability studies essential for submission to avoid unnecessary data while providing critical evidence, enabling a focused and efficient BLA preparation
- Integrate complex data sets for attributes like DAR distribution and impurity fate into a coherent narrative to facilitate regulator assessment of product consistency and control, reducing the risk of major objections and expedite the path to market