From Clinical Success to Commercial Launch Readiness: CMC Strategies for ADC BLA Readiness

• Building BLA readiness from early clinical development to commercialization
• Establishing robust process characterization and science-based control strategies
• Executing successful PPQ, validation, and regulatory inspection readiness
• Ensuring commercial launch readiness and reliable long-term supply

Speakers:

Michelle Zheng

Chief Strategy Officer

Zencore Biologics