Panel: Building Strategic CDMO Partnerships for CMC Success in the Age of Complex Biologics

Session details:

As biologics grow increasingly complex—spanning ADCs, bispecifics, cell and gene therapies, and mRNA—the demands on CDMOs have shifted from simple execution to true scientific collaboration. For preclinical and CMC teams, selecting and managing the right CDMO early can make or break timelines, tech transfer success, and regulatory readiness. This panel explores how biotech innovators are engaging CDMOs strategically to meet the challenges of scale-up, analytical development, and compliance in a global, fast-evolving landscape. Topics include early integration, quality systems, and lessons learned from working with novel modalities under compressed timelines.

• Modality-Aligned CDMO Strategy: Matching CDMO capabilities to biologics, gene therapies, or complex synthetic platforms
• Tech Transfer in the Real World: Ensuring readiness for scale-up and process validation through data and documentation alignment
• CMC Risk Planning: Proactively addressing challenges in stability, comparability, and analytics across development stages
• Regulatory-Ready Manufacturing: How CDMO partnerships are evolving to meet global regulatory demands for complex products.