Compliance-ready intact mass analysis of modified oligonucleotides and impurities using the BioAccord LC-MS System

As the pipeline for oligonucleotide-based therapeutics continues to grow, with >300 currently in clinical trials, along with an increased demand for GMP/GLP-validated oligonucleotide reagents (including primers, probes, gRNA) for clinical DNA testing/sequencing, the need for robust, compliance-ready LC-MS analysis of oligonucleotides has never been greater.

Waters has designed the BioAccord LC-MS System to deliver robust, reproducible separations and accurate mass performance in a compact, easy-to-use format; one that facilitates deployment across regulated development, manufacturing and QC labs and supports a range of routine biopharmaceutical analyses, including oligonucleotide analysis. In this webinar, hear from Dr. Catalin Doneanu about recent work demonstrating the utility of the BioAccord LC-MS system and find out how this system has helped users analyze and monitor a diverse range of modified oligonucleotides and known impurities using the compliance-ready intact mass analysis workflow.

Watch this webinar to:

• Learn how the BioAccord LC-MS system delivers robust UPLC separations performance and accurate mass data for a diverse range of modified oligonucleotides
• Learn how mass spectral deconvolution algorithms and isotopic models can impact mass accuracy, particularly for phosphothioated oligonucleotides, and how the BioAccord makes it easy to select the right combination.
• Discover how compliance-ready data acquisition, processing and reporting take the worry out of meeting data integrity and regulatory requirements.

Who should attend?

This webinar will provide insights for:

• Lab directors, managers and analytical scientists engaged in oligotherapeutic development, manufacturing, and QC
• Analytical scientists supporting the development and manufacturing of oligonucleotide primers and probes for PCR-based diagnostics, including targeted next-generation sequencing
• Incoming QC managers who verify the ID, purity, and quality of incoming oligonucleotides from third-party manufacturers

Presenter: Catalin E. Doneanu, Ph.D. (Principal Chemist, Waters Corporation)

Catalin Doneanu received his Ph.D. in analytical chemistry from Oregon State University in 2002. After a postdoctoral stage in the Department of Medicinal Chemistry at University of Washington in Seattle, he joined Waters Corporation in 2006. He is currently a principal scientist in the Biopharmaceutical Sciences group. He has more than twenty years of experience in separation sciences and mass spectrometry. His current research interests are in the area of therapeutic oligonucleotides and protein characterization using LC-MS. Catalin has over 30 peer-reviewed publications.

Carrie Haslam (Associate Editor, SelectScience)

Carrie Haslam is an Associate Editor at SelectScience, playing a key role in content production and specializing in Alzheimer’s disease and clinical diagnostics. She is finalizing her Ph.D. from Plymouth University, where she developed graphene-based biosensors for the early diagnosis of Alzheimer’s disease.