CMC Strategies for Advanced ADC Manufacturing: Overcoming Complexities & Optimizing for Success

As the ADC landscape advances toward more potent and precise therapies, manufacturers must evolve CMC strategies to keep pace. This session will explore practical strategies to streamline manufacturing while ensuring product quality, scalability, and regulatory compliance for next-generation ADCs.

• Optimizing bioconjugation for dual-payload ADCs, including cysteine conjugation and amino acid incorporation for controlled payload attachment
• Key manufacturing considerations to enable site-specific conjugation with scalability and consistency
• Developing robust analytical methods and CMC strategies to support global regulatory submissions for complex ADCs