Unveiling CQA Insights for mRNA, LNPs and Viral Vectors by SEC and MALS with Novel 1000 Å Ultrawide Pore Particle Columns

The recent pandemic has forced the field of medicine to witness groundbreaking advancements with the development and widespread adoption of novel therapeutic modalities, particularly concerning nucleic acid-based medicines. Among these, messenger RNA (mRNA), lipid nanoparticle (LNP) delivery systems, and viral vector-based medicines have emerged as transformative technologies, unlocking new possibilities for treating a myriad of genetic diseases and cancers. As such, ensuring the quality and integrity of these therapeutics becomes paramount.

Impurities and structural integrity issues can impact the safety and efficacy of these medicines. Herein lies the emerging significance of size exclusion chromatography (SEC) combined with MALS for impurity and integrity analysis. In this webinar, we will highlight the critical quality attributes using new 1000 Å ultrawide pore columns with MALS detection to resolve and analyze long-chain nucleic acids (RNA/DNA), lipid nanoparticles (LNPs) and viral vector formulations.

• Development of high-resolution and robust multiattribute methods for mRNA integrity and aggregate analysis
• Method conditions for Intact Lipid Nanoparticle (LNP) heterogeneity analysis
• Aggregate analysis and elucidating degradation pathways with high efficiency and low adsorption hardware using the new 1000 Å ultrawide pore columns

Presenter: Dr. Adam Crowe (Sr. Manager Analytical Development, Precision NanoSystems ULC - part of Cytiva)

Adam Crowe manages a mult-discipline team at Precision NanoSystems ULC (part of Cytiva) tasked with developing novel analytical assays related to lipid nanoparticles (LNP) and nanomaterials for drug delivery. Notably, Adam and his team have increasingly leveraged cutting-edge technologies, such as LC-MS approaches, to tackle complexities of LNP characterization. Latest studies were focused on the detail characterization of impurities found in ionizable liquids.

Presenter: Lavelay Kizekai (Principal Scientist, Waters Corporation, Milford, Massachusetts)

Lavelay Kizekai is a Principal Scientist at Waters Corporation. He joined Waters in 2009 and has since applied himself to developing new LC methods, leading column technology product development work, and establishing insight-based QC procedures for Waters products. His primary area of focus is biomolecule separations using Size-Exclusion Chromatography (SEC). He was a core member of the team that recently bought to market a column suited to platform methods for monoclonal antibodies and antibody drug conjugates. He is currently leveraging these SEC technologies and even newer breakthroughs for the characterization of gene-based therapeutics by multi-angle light scattering (SEC-MALS).

Presenter: Mandana Fasth (Principal Product Manager, Waters Corporation)

Mandana Fasth is the Global Principal Product Manager at Waters Corporation. She received her Master degree in Biochemistry from Uppsala university in Sweden. With more than 20 years' experience working with biologics workflows such as Sized-Exclusion Chromatography and column development projects, she is a well versed at training and supporting scientists with method development for characterization and purification of biologics.