RNA therapeutics characterization with automated LC-MS workflow

Join us for an insightful webinar on the characterization of RNA-based therapeutics using LC-MS and Thermo Scientific Chromeleon CDS. Learn about our automated intact deconvolution and reporting workflow in Chromeleon that enhances the efficiency and accuracy of RNA therapeutic analysis.

Oligonucleotides are an emerging powerful class of therapeutic modalities, for which robust and sensitive analytical methods are required. The primary structure of therapeutic RNA-based drugs is seen by regulatory agencies as a critical attribute and must be confirmed and quantified together with the 5′ and 3′ termini fragments and any site-specific modifications, to ensure sufficient quality, safety, and efficacy.

What You Will Learn

In this webinar, we will showcase:

• Amine-based ion pair reversed-phase (IPRP) LC coupled to a high-resolution MS and MS/MS method (HRMS) for sensitive characterization of several different single-stranded antisense oligonucleotides (ASOs).
• Evaluation of the applicability of an alternative ion pairing reagent, with moderate hydrophobicity, and the use of a mild ESI source, aiming to reduce the formation of ion pair-adducts and in-source induced impurities.
• Detailed impurity characterization of different therapeutic ASO RNA as well as sequencing of the primary structure of the full-length product (FLP) and impurities and degradation products by MS/MS.
• A new workflow and report setup in Chromeleon that enables an automated and high throughput intact LC-MS workflow for analysis of small oligonucleotides, including ASO RNA.

Learning Objectives

• Learn how to analyze ASO RNA by LC-MS with a fast and sensitive method to confirm identification, purity assessment, as well as to quantify and sequence impurities.
• Understand why high-resolution mass spectrometry is a powerful technique for oligonucleotide characterization, and how MS/MS sequencing of oligonucleotides in BioPharma Finder software can help confirm the identity and sequence of oligonucleotides.
• Discover best practices and tips & tricks for oligonucleotide analysis by LC-MS, including software solutions.
• Learn how to process intact oligonucleotide LC-MS in a compliant and automated high throughput fashion in Chromeleon CDS.

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Presenter: Dr. Silvia Millán Martín (Senior Research Scientist, National Institute for Bioprocessing Research and Training (NIBRT))

Silvia Millán Martín is a distinguished Senior mass spectrometry specialist at the National Institute for Bioprocessing Research and Training (NIBRT) in Dublin, Ireland. She collaborates with Thermo Fisher Scientific to develop innovative applications for the characterization of biopharmaceuticals. Her work encompasses a broad range of chromatographic techniques, ensuring comprehensive analytical solutions for the scientific and biopharmaceutical industries. Silvia's extensive background in analytical chemistry and her dedication to advancing biopharmaceutical characterization make her a leading expert in her field. Her recent work continues to push the boundaries of mass spectrometry applications, driving forward the capabilities of biopharmaceutical analysis and production.

Presenter: Dr. Ulrik H. Mistarz (Application Scientist, Thermo Fisher Scientific)

Dr. Ulrik Mistarz is a Senior Application Scientist at Thermo Fisher Scientific in Copenhagen, Denmark. He supports a broad range of LC-MS applications with a focus on developing novel workflows for characterization of oligonucleotides, therapeutic proteins, as well as different antibody formats.

He has a strong interest in improving the throughput and automation of analytical workflows through developing new LC-MS as well as software workflows.Ulrik Mistarz has a PhD from The Department of Pharmacy at the University of Copenhagen and has more than 10 years of experience with pharma/biopharma characterization and analytics. This includes positions in both pharmaceutical and biotech companies working on LC-MS and HPLC application development.