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 Director of Light Scattering in QC at Waters Corporation break down how the October 2025 FDA draft guidance is reshaping expectations for biosimilar development.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.

In this special Year in Review episode of Chromatography Life, host Neil Lander reflects on a year of engaging conversations with both Waters colleagues and customers from across the analytical science community. Neil shares what made each episode memorable, from deep technical insights to the personal stories behind the science.

In this episode, Neil Lander sits down with renowned analytical chemist Bob McDowall to explore the complexities of chromatographic peak integration. With over 50 years of experience, Bob shares insights into data integrity, regulatory compliance, and the evolving role of manual vs. automated integration. The conversation dives into real-world examples, AI's potential role in chromatography, and best practices for developing scientifically sound SOPs.