Characterization from pDNA to LNP: A Liquid Chromatography Approach for In-Process and Quality Control of LNP-based Biopharmaceuticals

Join this interactive workshop with hands-on demonstrations to learn and discuss about the characterization and manufacturing of LNP-based drug products. These require precise and robust control at multiple critical steps, from the production of plasmid DNA (pDNA) through in vitro transcription (IVT) of mRNA to final lipid nanoparticle formulation. Controlling the entire production process is critical to ensure product consistency, safety, and efficacy. This presentation introduces PATfix, a liquid chromatography-based analytical platforms designed to provide in-process control throughout the entire workflow of manufacturing and quality control of the drug substance and drug product. These platforms integrate liquid chromatographic methods tailored to monitor and characterize DNA, RNA, and LNPs throughout the entire manufacturing process. This solution combines hardware components and in-house software, monolithic analytical columns, and pre-validated analytical methods to precisely measure key quality attributes such as concentration, integrity, and purity. Case studies will demonstrate PATfix application in various stages of mRNA vaccine manufacturing, including pDNA lysis optimization, IVT reaction monitoring, and LNP characterization. The PATfix LNP Switcher, an advanced chromatography platform, addresses key LNP attributes, using two analytical columns and multiple detectors. It quantifies nucleic acid (NA) content, including free NAs, fragmented NAs, and NA-lipid adducts, while also determining particle heterogeneity, lipid composition, and purity. With its robust analytical capabilities, PATfix provides a reliable and scalable solution to support the evolving demands of the nucleic acid delivery field.