Analysis of oligonucleotides by accurate mass LC/MS: Sequencing and impurity analysis to support development at Arrowhead Pharmaceuticals

Oligonucleotides have grown to represent an increasingly important class of therapeutic modalities. During development of new chemical entities, it is critical to both determine sequences, and identify process impurities and degradation pathways using LC/MS. These tasks are further complicated by severe data analysis challenges, requiring significant time for execution by expert level users. The main reason for these challenges is due to the lack of automation, with users often relying on manual processing with user-generated spreadsheets. Agilent BioConfirm 12.0 has been expanded to contain oligonucleotide analysis capabilities, and examples from work at Arrowhead Pharmaceuticals will be presented in this webinar, showing expedited accurate mass LC/MS analyses.

Key learning objectives

• Gain background knowledge on oligonucleotide therapeutics, focusing mostly on siRNA
• Understand the importance of structure characterization and impurity identification, as well as the current challenges with existing software platforms
• Learn from a practical demonstration about a case where LC/MS analyses have been undertaken to confirm the molecular sequence, as well as to understand process impurities and degradants

Who should attend?

• QA/QC laboratories
• Biopharma analytical development scientists
• Biopharma process development scientists
• CDMO labs
• Diagnostic development labs

Presenter: Leo Joyce (PhD) (Senior Chemist, Arrowhead Pharmaceuticals)

Leo A. Joyce graduated with a BS in Chemistry from the University of Wisconsin-Madison in 2007. He went on to earn his PhD in Organic Chemistry from the University of Texas in 2012, developing optical sensors with Professor Eric Anslyn. From there Joyce went to work in industry, spending seven years in the Analytical R&D organization at Merck in Rahway, NJ. In 2019, he returned to Wisconsin, where he leads a team of Analytical scientists at Arrowhead Pharmaceuticals. He was recently named an Industrial Early Career Investigator by the American Chemical Society and has over 45 peer-reviewed publications.

Presenter: Blake Forman (Editorial Assistant, SelectScience)

Blake studied chemistry at the University of Surrey, UK, and further went on to study a master’s in chemistry at the University of Southampton, UK. Blake has previously worked in the Medicines and Healthcare Products Regulatory Agency (MHRA) lab at LGC and as a technical sales specialist for Waters. As a member of the Editorial team, he now plays an integral role in shaping the content on SelectScience.