Mastering Sequence Variant Analysis in Biotherapeutics

About This Webinar

False positives remain one of the biggest obstacles in sequence variant analysis, slowing data review and delaying critical biotherapeutic projects. While the technique is essential for ensuring safety and efficacy—since even subtle amino acid alterations can impact drug performance—technical scientists often face a heavy burden of false-positive results.

In this webinar, Dr. Zachary Lee of Catalent Pharma Solutions, a leading authority in protein analytics with over 12 years of LC-MS experience, will reveal how many of these false positives actually stem from predictable sample preparation artifacts. Drawing on extensive work with monoclonal antibodies, ADCs, bispecifics, and fusion proteins, he will share a systematic methodology using time-courses at each preparation step to distinguish true variants from artifacts during method development—transforming analytical workflows and accelerating project timelines.

 Key Takeaways

• Dramatically reduce analysis time by preventing false positives before they reach your data review process
• Improve data quality and confidence in variant identification through proven strategies
• Implement immediately applicable protocols that can be integrated into existing workflow

Dr. Zachary Lee brings over 12 years of specialized expertise in protein analytics using Liquid Chromatography Mass Spectrometry (LC-MS) to biotherapeutic characterization challenges. His comprehensive experience spans critical protein characterization methodologies including peptide mapping, intact mass analysis, sequence variant analysis, and host-cell protein analysis across diverse therapeutic platforms. Dr. Lee has led analytical teams in the characterization of monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), bispecifics, and fusion proteins, developing practical solutions to complex analytical challenges that directly impact regulatory submissions and product quality decisions. He holds a Ph.D. in Biology from the Stowers Institute for Medical Research, where he developed his foundation in advanced analytical techniques that continue to drive innovation in his current work.