Waters Corporation has launched the BioResolve™ Peptide and GTxResolve™ Lipid Phenyl-Hexyl+ and C18+ Columns, a reversed-phase column platform designed to improve separations for GLP-1 peptides, insulin, and lipid nanoparticle (LNP) drug substances.
The company announced the launch at the 55th International Symposium on High Performance Liquid Phase Separations and Related Techniques. Waters reports that the columns can deliver up to 3x faster GLP-1 characterization and 2x faster LNP component analysis. The platform also delivers up to a 2x increase in resolving power and sensitivity to identify and track low-level impurities.
GLP-1 receptor agonists and newer mRNA-based therapies, including in vivo CAR T, require methods that can resolve structurally and chemically similar impurities. Waters reports that poor impurity resolution can delay time to market, weaken regulatory confidence, and affect patient safety.
Traditional reversed-phase columns may require longer analyses, mobile-phase additives that suppress detector response, or repeated method redevelopment. BioResolve Peptide and GTxResolve Lipid Columns use specially designed surface chemistries and superficially porous particles to improve resolution and speed while fitting into existing workflows.
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"We have made simultaneous advances in both chemistry and particle physics to deliver the first columns Waters has introduced to market specifically QC batch-tested for GLP-1 analysis and lipid nanoparticles, solving a longstanding customer pain point," said Erin Chambers, Vice President, General Manager, Consumables & Lab Automation, Waters Analytical Sciences, Waters Corporation. "BioResolve Peptide and GTxResolve Lipid Columns are designed to resolve chemically similar GLP-1 impurities and LNP components faster when speed matters, and with extraordinary resolution when certainty is required."
GLP-1 peptides pose analytical challenges because some impurities differ by one atom, while others share the same atomic composition and differ only in spatial arrangement. BioResolve Peptide Phenyl-Hexyl+ and C18+ Columns target these impurities, with 300 mm formats available for deeper impurity characterization.
"The BioResolve Peptide RP Columns have performed exceptionally well, showing outstanding resolution between our peptide therapeutics and related impurities," remarks Ashish Kanhed, Group Leader, Alembic Pharmaceuticals. "We are highly impressed with their quality and look forward to continuing to use them for our complex GLP-1 and peptide separations."
For LNP and lipid workflows, GTxResolve Columns use a charged surface to sharpen peaks for ionizable lipids by reducing tailing. Waters reports that the larger pore size helps a wide range of lipid molecules move through the column, improving peak shape and resolving difficult co-elutions.
"GTxResolve Lipid RP Columns have demonstrated strong performance for lipid quantitation and impurity analysis, with reduced run times and excellent peak shape," comments Adam Kowalczyk, Research Scientist II, Analytical Development, Acuitas Therapeutics. "The ability to tune separations for specific lipid components, combined with compatibility across multiple detector platforms (UV, MS, ELSD, and CAD), provides significant flexibility for characterization of diverse lipid species."
This article is based on a press release issued by Waters.
