Mastering Sequence Variant Analysis in Biotherapeutics
Reduce False Positives, Streamline Workflows, and Gain Confidence in Sequence Variant Analysis
About This Webinar
False positives are the primary bottleneck in sequence variant analysis, often requiring weeks of manual data review that delays critical biotherapeutic development timelines. In this webinar replay, Dr. Zachary Lee from Catalent Bioanalytics demonstrates how systematic sample preparation strategies can dramatically reduce false positives by identifying predictable artifacts before they reach data analysis. Drawing from extensive experience with mAbs, ADCs, and other biologics, he shares practical methodologies that transform analytical workflows from reactive troubleshooting to proactive quality control.
Key Takeaways
- Cut analysis time from weeks to days by eliminating false positives during method development rather than data review
- Build confidence libraries of known artifacts specific to your protein and sample prep conditions
- Implement time-course and dual-reagent strategies that quickly distinguish true variants from preparation artifacts
- Apply vendor-neutral approaches that work across different mass spectrometry platforms and protein types
From the Webinar
"Many studies cite around a two week data processing time for sequence variants, and this is fairly accurate in our experience. But with this approach, that time is reduced dramatically, leaving critical manufacturing decisions and timelines kind of unimpacted for example, a clone selection study." (34:53)
"We also use Protein Metrics Byos software, which has built in a number of validators that essentially flag suspect assignments for closer inspection." (21:14)
"And so this kind of leaves us unhindered in our data analysis by a large proportion of the false positives, so that we can quickly, work through actual sample testing quickly, accurately, and efficiently." (34:25)
About the Speaker
Dr. Zachary Lee brings over 12 years of specialized LC-MS expertise to biotherapeutic characterization challenges. As Lead Scientist, Mass Spectrometry at Catalent Bioanalytics, he has developed practical solutions for sequence variant analysis across monoclonal antibodies, ADCs, bispecifics, and fusion proteins. His systematic approach to reducing false positives has directly impacted regulatory submissions and accelerated product development timelines. Dr. Lee holds a Ph.D. in Biology from the Stowers Institute for Medical Research and leads analytical teams supporting drug development from discovery through commercial manufacturing.
Recorded 17-Sep-25