Characterising Complex Biotherapeutics Based on New Modalities: Uncover new LC-MS Workflow Strategies
The rapid expansion of complex biotherapeutic modalities such as RNA-based therapies is pushing conventional LC–MS workflows beyond their limits. Even though there has been great progress in oligonucleotide drug development and approval there is still significant regulatory and analytical challenges in this field. Characterisation guidelines are still under development and must account for unique challenges. Regarding impurity characterisation, most impurities exist as mixture of closely related molecules and even worse, many impurities coelute with the active molecule. Many existing approaches struggle to deliver reliable separation and high-quality MS data to adequately resolve those impurities. Challenges such as good chromatographic resolution, metal adduct formation, and inconsistent MS data quality are increasingly impacting characterisation workflows.
In this webinar, we introduce a next-generation LC–MS strategy designed to address these gaps. By combining advanced reversed-phase chromatography with an inert UHPLC flow path, this workflow improves separation of challenging species, minimizes metal adducts, and delivers more consistent, more interpretable MS data across diverse modalities.
Using the Thermo Scientific™ SurePac™ RP MDi™ column on the Thermo Scientific™ Vanquish™ Amplify UHPLC system coupled with Orbitrap™ MS, we will demonstrate how this approach enhances analytical performance in real-world applications, including impurity profiling for small single stranded oligonucleotide therapeutics, such as antisense oligonucleotides (ASOs), using a DoE-driven approach.
Learning Objectives:
Understand how advanced LC-MS workflows support characterization across new modalities such as ASOs, including detection of critical quality attributes such as the confirmation of the primary structure together with the analysis of the 5′ and 3′ termini, and any site-specific modification and the detailed analysis of product-related impurities.
Evaluate how inert column technologies and UHPLC systems improve reproducibility, reduce sample interaction, minimize metal adducts and enhance robustness for complex biotherapeutic workflows.
Apply design of experiments (DoE) driven method optimization and LC–MS approaches for impurity profiling, and comprehensive characterization.
Join us to see how this workflow can unlock deeper characterization and more confident results across today’s most demanding biotherapeutic modalities.