en.Wedoany.com Reported - Waters Corporation announced at the 55th International Symposium on High-Performance Liquid Phase Separations and Related Technologies the launch of the BioResolve Peptide and GTxResolve Lipid Phenyl-Hexyl+ and C18+ columns. This column platform, the first of its kind in the industry, is designed to support the development of safe and effective drug products by reliably separating structurally and chemically similar impurities in GLP-1 peptides, insulin, and lipid nanoparticles (LNPs). According to Waters, the product accelerates run times for GLP-1, insulin, and LNP drug substance testing, shortening biopharmaceutical development cycles and reducing production bottlenecks; it delivers up to a two-fold improvement in resolution and sensitivity, helping to identify and track low-level impurities and enhancing regulatory readiness.
In the development of GLP-1 receptor agonists and mRNA-based novel therapies (such as in vivo CAR T), difficult-to-separate impurities can delay time-to-market, undermine regulatory confidence, and impact patient safety. Traditional reversed-phase (RP) columns often struggle to effectively separate low-level or closely related impurities, requiring longer analysis times, the use of detector-suppressing mobile phase additives, or repeated method development. The BioResolve Peptide and GTxResolve Lipid columns overcome these limitations with ready-to-use methods, improving resolution and speed while integrating into existing workflows.
According to Erin Chambers, Vice President and General Manager of Consumables and Lab Automation at Waters' Analytical Science Division, the new columns represent advances in both chemistry and particle physics, achieving proprietary designs tailored for GLP-1 analysis and lipid nanoparticle quality control batch testing. The columns are designed to more rapidly separate chemically similar GLP-1 impurities and LNP components, while providing higher resolution when needed. This helps streamline method development, ensure data meets regulatory requirements, and enables faster, highly reproducible methods to reduce the cost burden of important new therapies.
The BioResolve Peptide and GTxResolve Lipid columns feature specially designed surface chemistry and superficially porous particles, enabling precise reversed-phase separation for two challenging sample types. The products offer two bonded phases, Phenyl-Hexyl+ and C18+, with a pore size of 230 Å, delivering consistent performance on both U(H)PLC and HPLC systems, and providing reliable, batch-tested results from early research through production.
Analysis of GLP-1 peptides is particularly challenging, as many impurities differ by only a single atom or in spatial arrangement. The BioResolve Peptide Phenyl-Hexyl+ and C18+ columns are designed to separate these difficult impurities, with a 300 mm format available for in-depth impurity characterization requiring greater separation performance.
Ashish Kanhed, Head of Department at Alembic Pharmaceuticals, stated that the BioResolve Peptide RP column demonstrates exceptional resolution between peptide therapeutics and related impurities. By rapidly distinguishing critical impurities using mass spectrometry-based quality control methods, the company can now meet current and future regulatory requirements in a single run, obtaining answers on molecular purity faster and more reliably.
For LNP and lipid workflows, the charged surface of the GTxResolve columns sharpens peaks for ionizable lipids by reducing tailing. The larger pore size improves peak shape and addresses co-elution issues, while the superficially porous particle design shortens run times without compromising selectivity.
Adam Kowalczyk, Associate Research Scientist in Analytical Development at Acuitas Therapeutics, noted that the GTxResolve Lipid RP column reduces run times for lipid quantification and impurity analysis while delivering excellent peak shape. The column allows adjustment of separation conditions for specific lipid components and is compatible with multiple detector platforms, offering flexibility for characterizing different lipid species. Notably, it achieves previously unattainable separation of ionizable lipids.
The Waters BioResolve Peptide and GTxResolve Lipid columns will be globally available starting June 9, 2026, with the 1.6 µm Phenyl-Hexyl+ stationary phase launching first.
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