1.) Course Description
In this workshop, you’ll explore the latest chromatographic techniques for analyzing complex non-viral drug modality formulations. We’ll utilize multidimensional chromatography systems and methods that streamline analytical workflows, enhance formulation predictions, and deepen understanding of passive and active organ targeting with LNP-based formulations.
2.) Who Should Attend?
◾︎ Researchers and PD scientists, particularly those engaged in gene therapy, RNA delivery, and nanoparticle pharmaceuticals, are seeking the latest analytical advances.
◾︎ Manufacturers seeking analytical support to monitor critical quality attributes throughout the entire process, from DNA to LNP finished drug product.
◾︎ Formulation professionals involved in formulating nucleic acids and lipid nanoparticle technologies.
◾︎ Quality control professionals interested in advanced chromatography techniques for biopharmaceutical characterization.
3.) Key Learnings
◾︎ Explore innovative analytical methods for LNPs that provide valuable insights into particle heterogeneity, nucleic acid content and quality, and lipid composition.
◾︎ Learn how multiple cargo formulations, like those used for CAR-T therapies, CRISPR gene editing, and combination vaccines, are analyzed using chromatographic methods. In detail, you will learn how to determine critical quality attributes like nucleic acid (NA) content—including free NA, fragmented NA, and NA-lipid adducts—while also assessing parameters like particle heterogeneity, lipid composition, and purity. Additionally, nanoparticles with targeting moieties are addressed to determine the effectiveness of conjugation, heterogeneity of the amount of surface ligand, and its orientation, leading to comprehensive analytics.
◾︎ Furthermore, learn how chromatographic techniques are used to isolate the LNP–protein corona complex and to analyze its composition, as well as the relationship between the corona and biodistribution of LNPs.
◾︎ Discover the latest data analysis software, PATfix, and see how it can assist in supporting your analytics efforts.