Oligonucleotides
As oligonucleotide therapeutics rapidly emerge as a transformative class of medicines, ensuring their quality and safety has become more critical than ever. In this webinar, Xiaolei Zhuang from the United States Pharmacopeia (USP) will discuss challenges in oligonucleotide quality assessment and USP’s solutions to support reliable analysis. Dr. Bala Addepalli from Waters will explore how tunable enzymes and streamlined informatics enable precise sequencing of mRNA and associated impurities—all within a single LC-MS run.
Key Learning Objectives
- Gain insights into overcoming analytical challenges in oligonucleotide therapeutics
- Discover USP’s products and solutions that enhance quality and consistency
- Explore comprehensive tools to streamline and automate oligonucleotide sequence confirmation, ensuring robust mapping workflows for routine RNA analysis in a GMP environment
Who Should Attend
- Analytical scientists involved in oligonucleotide analysis
Presenter: Xiaolei Zhuang (Principal Scientist, Global Biologics, US Pharmacopeia)
Xiaolei Zhuang is a Principal Scientist in Global Biologics at USP, where she leads the development of reference standards for mAb, insulin, endotoxin and other biologic products. She brings extensive expertise in analytical development, with a strong emphasis on bioassays. Prior to joining USP, she worked in the biopharmaceutical industry, supporting the development of biological therapeutics through analytical, preclinical, and clinical studies, with a focus on CMC components.
Presenter: Dr Bala Addepalli, Ph.D., (Director R&D, Waters Corporation)
Dr. Bala Addepalli has an impressive background in the field of cell and gene therapy product analysis. Currently, he is the Director of the Evaluations and Application Science Team under the Genetic Medicine analysis portfolio at Waters Corporation. His work focuses on developing efficient analytical approaches for characterization of DNA, RNA, LNPs(lipid nanoparticles), and viral vectors using liquid chromatography coupled with mass spectrometry or light scattering techniques. Before joining Waters, Bala made significant contributions at the University of Cincinnati, where he developed novel enzymes and analytical methods for RNA characterization. His earlier work includes research on mRNA polyadenylation at the University of Kentucky, and viral RNA characterization during his graduate studies in India. With over 60 publications and numerous presentations at scientific meetings, Bala's expertise is well-recognized in the scientific community.
Moderated by: Samuel Seal (Biopharma Market Development Manager, Waters Corporation)
Samuel Seal is a market development manager specializing in the biologics space. He loves LC and MS – especially on how this technology provides benefit and value.
Sam joined Waters in January of 2014 as a Sales Technical Support Specialist in the Irvine office/lab. As a TSS he performed demonstrations on various instruments, provided training for customers, often presented on technical information at varying events, and assisted with troubleshooting from Colorado to Los Angeles. He previously worked at Pyxant Labs in Colorado Springs, CO where he gained extensive experience developing and validating methods for small/large molecules in bioanalytical assays, agricultural commodities, registration of pesticides, and worker exposure studies. He also has experience in column chromatography, sample extraction, sample clean-up, reporting and data management. Sam has hands on experience with running and maintaining various manufacturers' LC/MS/MS systems. Prior to Pyxant, Sam was a Laboratory Instructor at the University of Colorado at Colorado Springs where he earned his Bachelor of Arts in Biology and Bachelor of Arts in Chemistry.
