Waters Corporation has launched the BioResolve Peptide and GTxResolve Lipid Phenyl-Hexyl+ and C18+ Columns, a reversed-phase column platform engineered to address one of analytical development's most persistent biopharmaceutical challenges: reliably separating structurally and chemically similar impurities in GLP-1 peptides, insulin, and lipid nanoparticles (LNPs).
The columns were announced June 8, 2026 at the 55th International Symposium on High Performance Liquid Phase Separations and Related Techniques, and became available globally on June 9, 2026, starting with the 1.6 µm Phenyl-Hexyl+ phase. They are the first columns Waters has introduced to market specifically QC batch-tested for GLP-1 analysis and lipid nanoparticles, a distinction the company says addresses a longstanding customer pain point in biopharmaceutical quality control.
Why GLP-1 and LNP analysis has been so difficult
The analytical challenge these columns target is rooted in the molecular complexity of the sample types involved. GLP-1 peptides present a particularly demanding separation problem: many impurities differ by just a single atom, while others have identical atomic composition and vary only in how their atoms are spatially arranged. Standard reversed-phase columns frequently struggle to resolve these closely related species without resorting to longer run times, detector-suppressing mobile-phase additives, or cycles of method redevelopment that consume time and resources.
LNP workflows present a different but equally persistent problem. Ionizable lipids and other LNP components are prone to peak tailing, and the structural diversity across lipid species makes co-elution a recurring obstacle. In both GLP-1 receptor agonists and newer mRNA-based therapies such as in vivo CAR T, difficulty resolving impurities can delay time to market, weaken regulatory confidence, and, in the worst cases, affect patient safety.
Waters states the BioResolve Peptide and GTxResolve Lipid Columns deliver up to 3x faster GLP-1 characterization and 2x faster LNP component analysis than previous approaches, alongside up to 2x higher resolving power and sensitivity for low-level impurity identification. All performance figures are vendor-stated and supported by referenced data on file.
What sets the columns apart technically
Both column families use specially designed surface chemistries and superficially porous particles to deliver precise reversed-phase separations with selectivity for their respective difficult sample types. Available in Phenyl-Hexyl+ and C18+ chemistries with 230 Å pore size particles, they are designed to support efficient mass transfer and consistent performance across U(H)PLC and HPLC systems from early-stage research through manufacturing. Ready-to-use methods fit into existing workflows, reducing the need for extensive method redevelopment before labs can begin generating regulatory-ready data.
For GLP-1, the specialized 300 mm column formats are available when maximum separation performance and deeper impurity characterization are required. For LNP workflows, the charged surface of the GTxResolve columns sharpens peaks for ionizable lipids by reducing tailing, and the larger pore size makes it easier for a wide range of lipid molecules to move through the column. The superficially porous particle design speeds the movement of molecules through the stationary phase, shortening run times without reducing selectivity.
Key specifications and features at a glance:
| Feature | BioResolve Peptide | GTxResolve Lipid |
|---|---|---|
| Target applications | GLP-1, insulin, peptide therapeutics | Lipid nanoparticles, ionizable lipids |
| Chemistries available | Phenyl-Hexyl+, C18+ | Phenyl-Hexyl+, C18+ |
| Particle type | Superficially porous | Superficially porous |
| Pore size | 230 Å | 230 Å |
| Availability (first phase) | 1.6 µm Phenyl-Hexyl+ from June 9, 2026 | 1.6 µm Phenyl-Hexyl+ from June 9, 2026 |
| Extended format | 300 mm available for maximum resolution | Standard formats |
| System compatibility | U(H)PLC and HPLC | U(H)PLC and HPLC |
The case for QC batch-testing
A recurring challenge in biopharmaceutical analytical method development is variability between column lots. For regulated applications where methods must produce reproducible results run to run and batch to batch, lot-to-lot inconsistency in column chemistry adds an unpredictable variable to what are already complex separations. Waters' positioning of these columns as specifically QC batch-tested for GLP-1 and LNP applications is an attempt to address that problem directly, providing labs with a starting point for validated methods that is less likely to require recalibration as column stock turns over.
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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 and 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. The result is simpler method development, regulatory-ready data, and faster, highly reproducible methods, ultimately helping to reduce cost burdens on important new therapeutics."
Customer perspectives from pharmaceutical and gene therapy settings
Two external collaborators offered assessments of the columns in their respective workflows.
Ashish Kanhed, Group Leader at Alembic Pharmaceuticals, reported strong performance for GLP-1 work. "The BioResolve Peptide RP Columns have performed exceptionally well, showing outstanding resolution between our peptide therapeutics and related impurities," he said. "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."
Interested in life sciences?
For LNP workflows, Adam Kowalczyk, Research Scientist II, Analytical Development at Acuitas Therapeutics, highlighted both flexibility and a separation capability that had not been previously achievable. "GTxResolve Lipid RP Columns have demonstrated strong performance for lipid quantitation and impurity analysis, with reduced run times and excellent peak shape," he said. "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."
Acuitas Therapeutics is a Vancouver-based private biotechnology company widely recognized for its foundational work on LNP delivery systems, including the technology underpinning the Pfizer-BioNTech COVID-19 mRNA vaccine.
What this means for biopharma analytical labs
The timing of this launch reflects the analytical pressure now being felt across biopharma development pipelines. GLP-1 receptor agonists have become some of the most commercially valuable drug classes in history, and the pipeline of biosimilars and next-generation analogues is generating significant demand for faster, more reliable impurity characterization methods. Simultaneously, mRNA therapeutics and in vivo gene therapies are placing new demands on lipid analysis workflows, as regulatory requirements for analytical method validation continue to evolve for these newer modalities.
For lab managers evaluating these columns, the key practical questions are whether the QC batch-testing translates meaningfully into reduced lot-to-lot variability in their specific workflows, and whether the ready-to-use methods require significant adaptation before they can support regulated submissions. The multi-detector compatibility highlighted by Kowalczyk is also worth noting for labs that run orthogonal detection strategies.
For more information, visit waters.com/BioResolve and waters.com/GTx.
References
Waters Corporation. "Waters Launches Industry-First Reversed-Phase Bioseparation Columns to Deliver Up to 3x Faster GLP-1 Characterization and 2x Faster LNP Component Analysis." PR Newswire, June 8, 2026. https://www.prnewswire.com/news-releases/waters-launches-industry-first-reversed-phase-bioseparation-columns-to-deliver-up-to-3x-faster-glp-1-characterization-and-2x-faster-lnp-component-analysis-302793755.html
Acuitas Therapeutics. "About Acuitas." Accessed June 2026. https://www.acuitastx.com
Alembic Pharmaceuticals. "Company Overview." Accessed June 2026. https://www.alembicpharmaceuticals.com
