In this episode of Chromatography Life, Neil Lander and Colette Quinn, Sr. Director of Light Scattering in QC at Waters Corporation break down how the October 2025 FDA draft guidance is reshaping expectations for biosimilar development. They explore why LC and orthogonal techniques like MALS are becoming essential for demonstrating analytical similarity and reducing reliance on clinical studies. Colette also highlights how tools like Empower™ Software support data integrity, reproducibility, and faster development timelines.
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