EVENTS
November 13th, 2025 MEETING at Waters IMMERSE LAB in Cambridge
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- SPEAKER: Steve Shiner, Waters Corporation
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- TITLE: From GLP's to LNP's: Recent Advances in Size-based Separations.
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- ABSTRACT:
- Size exclusion chromatography (SEC) has long been a cornerstone technique for characterizing biotherapeutic drugs, particularly for detecting size variants that can impact efficacy or trigger immunogenic responses. High and low molecular weight species are now recognized as critical quality attributes, making their accurate quantitation essential for drug development and manufacturing. However, the latest generation of biotherapeutics—such as fatty acid–modified peptides, viral vectors, and nanoparticle formulations—introduces new analytical challenges. Design features that enhance therapeutic performance often increase secondary interactions, leading to poor recovery and resolution in SEC. Mitigation strategies, while helpful, can introduce conformational variability, stability concerns, or method-induced artifacts. To address these complexities, a new class of SEC columns has been developed, featuring highly inert particle and hardware surfaces combined with purpose-tuned pore diameters. When paired with best practices and advanced complementary detection techniques like multi-angle light scattering (MALS) and mass spectrometry (MS), these columns deliver robust, reliable characterization of complex modalities. This presentation will highlight the capabilities of next-generation SEC columns and emphasize the importance of optimized workflows. We will demonstrate how these advancements enable significant improvements in the analysis of size variants across a broad range of biotherapeutics and gene therapies—from peptides to large lipid nanoparticles and viral vectors—ultimately supporting the development of transformative medicines.
SPEAKER:
- Steve Shiner is a Technical Manager in the Bio-separations Consumables Portfolio at Waters Corporation, where he has spent over 22 years designing and developing innovative HPLC and UPLC column technologies. With specialized expertise in size exclusion chromatography and column packing process development, Steve has played a pivotal role in advancing analytical solutions for size-based separations of complex biomolecules. Prior to joining Waters, he worked in the environmental science industry and earned his degree in geology from the University of Colorado.
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