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News Summary:
- Shortens run times for GLP-1, insulin, and LNP drug substance testing, accelerating biopharmaceutical development and reducing production bottlenecks.
- Delivers up to 2x improvement in resolution and sensitivity, enabling identification and tracking of low-level impurities to enhance regulatory compliance readiness.
- Industry-first chemical and physical particle optimization technology provides reproducible methods for increasingly complex biologics.
MILFORD, MassachusettsJune 9, 2026 /PRNewswire/ — 55th International Symposium on High-Performance Liquid Phase Separations and Related Technologies – Waters Corporation (NYSE: WAT) today announced the launch of BioResolve™ Peptide and GTxResolve™ Lipid Phenyl-Hexyl+ and C18+ Columns. This industry-innovative reversed-phase (RP) column platform is specifically designed to address a long-standing challenge in biopharmaceuticals: reliably separating structurally and chemically similar impurities in GLP-1 peptides, insulin, and lipid nanoparticles (LNPs) to support the development of safe and effective drug products.
In the development of GLP-1 receptor agonists and novel mRNA therapies (such as in vivo CAR T), difficulties in impurity separation often lead to delayed market approvals, diminished regulatory confidence, and compromised patient safety. Traditional reversed-phase columns perform poorly in separating low-abundance or highly structurally similar impurities, typically requiring longer analysis times, reliance on mobile phase additives that suppress detector signals, or repeated method redevelopment. The BioResolve Peptide and GTxResolve Lipid Columns overcome these limitations with ready-to-use methods, achieving simultaneous improvements in resolution1,2 and analysis speed2,3 while remaining compatible with existing workflows.
BioResolve Peptide and GTxResolve Lipid Columns are 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.
Erin Chambers, Vice President of the Analytical Science Business Unit and General Manager of Consumables and Lab Automation at Waters, stated: “We have achieved a dual breakthrough in chemical packing and particle physical structure, launching Waters’ first columns specifically QC batch-tested for GLP-1 analysis4 and lipid nanoparticles2, solving a long-standing customer pain point. The BioResolve Peptide and GTxResolve Lipid Columns are designed to separate chemically similar GLP-1 impurities and LNP components at faster speeds2,3 while providing exceptional resolution1 when confirmatory results are needed. This not only simplifies method development and provides compliant data5, but also offers customers fast and highly reproducible analytical methods, ultimately reducing the cost burden of important new therapies.”
The BioResolve Peptide and GTxResolve Lipid Columns utilize specially designed surface chemistry and superficially porous particle technology to deliver highly accurate reversed-phase separation selectivity for these challenging sample types. The column series is available in both Phenyl-Hexyl+ and C18+ chemistries, using 230 Å pore size particles designed to support efficient mass transfer, ensure performance consistency across U(H)PLC and HPLC systems, and provide reliable batch-to-batch results5 throughout the entire process from early R&D to commercial production.
Analysis of GLP-1 peptides is extremely challenging because many impurities differ by only a single atom, and some even have identical atomic compositions, differing only in spatial arrangement. The BioResolve Peptide Phenyl-Hexyl+ and C18+ Columns are specifically built to separate such stubborn impurities and are available in a special 300 mm length to meet greater separation performance needs and deeper impurity characterization.
Ashish Kanhed, Group Head at Alembic Pharmaceuticals, commented: “The BioResolve Peptide reversed-phase columns have performed exceptionally well, demonstrating outstanding resolution in separating our peptide therapeutics and related impurities. We are very impressed with the quality of this product and look forward to applying it consistently to our complex GLP-1 and peptide separation projects. With rapid identification of critical impurities using mass spectrometry-based QC methods, we can now achieve compliance with current and future regulatory requirements in a single run, obtaining molecular purity data faster and with greater confidence.”
For LNP and lipid workflows, the GTxResolve columns feature a charged surface that helps reduce tailing and sharpen peaks for ionizable lipids. The larger pore size facilitates easier penetration of various lipid molecules into the column, improving peak shape and addressing co-elution challenges. Additionally, the superficially porous particle design accelerates molecular movement through the stationary phase, effectively shortening run times2 without sacrificing selectivity.
Adam Kowalcyk, Research Scientist II in Analytical Development at Acuitas Therapeutics, stated: “The GTxResolve Lipid reversed-phase columns have demonstrated excellent performance in lipid quantification and impurity analysis, not only shortening run times but also providing superior peak shapes. This ability to optimize separation for specific lipid components, combined with compatibility across multiple detector platforms (UV, MS, ELSD, and CAD), offers great flexibility for characterizing diverse lipid species. Notably, we observed separation of ionizable lipids that was previously unattainable with this column.”
Waters BioResolve Peptide and GTxResolve Lipid Columns will be available globally starting June 9, 2026, with the initial launch of 1.6 µm Phenyl-Hexyl+ columns. For more information, please visit the BioResolve Premier Columns and Gene Therapy (GTx) Analysis Dedicated Columns product pages.
Additional Resources:
- BioResolve Peptide Columns Product Page
- GTxResolve Lipid Columns Product Page
Waters, BioResolve, and GTxResolve are trademarks of Waters Corporation or its affiliates. All other trademarks are the property of their respective owners.
About Waters Corporation
Waters Corporation (NYSE: WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of cutting-edge science through analytical technology, informatics, and services. We focus on regulated, high-throughput testing, with an innovative product portfolio that integrates deep scientific expertise in chemistry, physics, and biology. We collaborate with customers worldwide to advance the launch of high-quality drugs, ensure food and water safety, and improve patient health through early disease detection, routine infection management, and antimicrobial resistance prevention. Driven by a shared culture of relentless innovation, our approximately 16,000 passionate employees worldwide transform scientific challenges into breakthroughs that benefit the globe.
References:
- Application Note: “Automating Charged Aerosol Detection (CAD) Analysis with Empower™ CDS Using a Single-Vendor Integrated LC Platform”
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