Waters Launches Industry-First Reversed-Phase Bioseparation Columns for Faster GLP-1 and LNP Analysis
核心洞察
Waters Corporation (搜索) unveils BioResolve Peptide and GTxResolve Lipid Columns, the first reversed-phase columns specifically QC batch-tested for GLP-1 peptides and lipid nanoparticles.
The new platform delivers up to 3x faster GLP-1 characterization and 2x faster LNP component analysis compared to existing fully porous particle technologies.
Up to 2x increase in resolving power and sensitivity enables better identification and tracking of low-level impurities, improving regulatory readiness.
MILFORD, Mass. — Waters Corporation (搜索) (NYSE: WAT) announced on June 8, 2026, at the 55th International Symposium on High Performance Liquid Phase Separations and Related Techniques the launch of the BioResolve™ Peptide and GTxResolve™ Lipid Phenyl-Hexyl+ and C18+ Columns. This first-of-its-kind reversed-phase (RP) column platform is engineered to address a persistent biopharmaceutical challenge: reliably separating structurally and chemically similar impurities in GLP-1 peptides, insulin, and lipid nanoparticles (LNPs) to support the development of safe, effective drug products.
The new columns deliver up to 3x faster GLP-1 characterization and up to 2x faster LNP component analysis, while providing up to a 2x increase in resolving power and sensitivity to identify and track low-level impurities. These performance gains are designed to accelerate biopharmaceutical development timelines and reduce production bottlenecks.
Addressing a Critical Analytical Gap
In GLP-1 receptor agonists (搜索) and newer mRNA-based therapies such as in vivo CAR T, difficulty resolving impurities can delay time to market, weaken regulatory confidence, and affect patient safety. Traditional RP columns do not always separate low-level or closely related impurities well, often requiring longer analyses, detector-suppressing mobile-phase additives, or repeated method redevelopment.
“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 (搜索). “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. The result is simpler method development, regulatory‑ready data, and faster, highly reproducible methods, ultimately helping to reduce cost burdens on important new therapeutics.”
Technical Innovation in Particle Design
BioResolve Peptide and GTxResolve Lipid Columns use specially designed surface chemistries and superficially porous particles to deliver precise RP separations with selectivity for two difficult sample types. Available in Phenyl-Hexyl+ and C18+ chemistries with 230 Å pore size particles, they are designed to support efficient mass transfer, consistent performance across U(H)PLC and HPLC systems, and reliable, batch-tested results from early-stage research through manufacturing.
GLP-1 peptides present a particularly formidable analytical challenge because many impurities differ by just one atom, while others have no difference in atomic composition and vary only in how their atoms are arranged spatially. BioResolve Peptide Phenyl-Hexyl+ and C18+ Columns are built to resolve these difficult impurities, with specialized 300 mm formats available when maximum separation performance and deeper impurity characterization are required.
Early User Validation
Ashish Kanhed, Group Leader at Alembic Pharmaceuticals, reported strong performance: “The BioResolve Peptide RP Columns have performed exceptionally well, showing outstanding resolution between our peptide therapeutics and related impurities. We are highly impressed with their quality and look forward to continuing to use them for our complex GLP-1 and peptide separations. By discriminating critical impurities at speed with a mass spectrometry-based QC approach, we can now satisfy present and future regulatory requirements in one run for faster, more confident answers on molecular purity.”
For LNP and lipid workflows, the charged surface of GTxResolve Columns helps sharpen peaks for ionizable lipids by reducing tailing. Their larger pore size facilitates movement of a wide range of lipid molecules through the column, improving peak shape and resolving challenging co-elutions. The superficially porous particle design also speeds the movement of molecules through the stationary phase, shortening run times without reducing selectivity.
Adam Kowalczyk, Research Scientist II, Analytical Development at Acuitas Therapeutics (搜索), noted: “GTxResolve Lipid RP Columns have demonstrated strong performance for lipid quantitation and impurity analysis, with reduced run times and excellent peak shape. 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. In particular, we have observed a separation of ionizable lipids that has not previously been achieved.”
Availability
Waters' BioResolve Peptide and GTxResolve Lipid Columns will be available globally beginning June 9, 2026, starting with the 1.6 µm Phenyl-Hexyl+ phase. QC batch testing approaches based on insulin, semaglutide, tirzepatide, cagrilintide, and liraglutide have been validated and documented in Waters' application literature.