Waters Corporation has announced the launch of the BioResolve Peptide and GTxResolve Lipid Phenyl-Hexyl+ and C18+ Columns, a first-of-its-kind reversed-phase column platform designed to address a persistent challenge in biopharmaceutical development: reliably separating structurally and chemically similar impurities in GLP-1 peptides, insulin, and lipid nanoparticles (LNPs). These columns are the first from Waters to be specifically QC batch-tested for GLP-1 analysis and LNP components, solving a longstanding customer pain point.
Key Benefits for Biopharmaceutical Development
The new columns deliver up to three times faster GLP-1 characterization and twice faster LNP component analysis compared to traditional reversed-phase columns. Faster run times for GLP-1, insulin, and LNP drug substance testing accelerate biopharmaceutical development timelines and reduce production bottlenecks. Additionally, the columns provide up to a two-fold increase in resolving power and sensitivity, enabling identification and tracking of low-level impurities for improved regulatory readiness.
Industry-First Optimization
The industry-first chemical and physical particle optimization ensures reproducible methods for increasingly complex biologics. Traditional reversed-phase columns often struggle to separate low-level or closely related impurities, requiring longer analyses, detector-suppressing mobile-phase additives, or repeated method redevelopment. The BioResolve Peptide and GTxResolve Lipid Columns overcome these limitations with ready-to-use methods that improve both resolution and speed while fitting into existing workflows.
Solving a Longstanding Pain Point
Erin Chambers, Vice President, General Manager, Consumables & Lab Automation, Waters Analytical Sciences, stated: "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. 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 Specifications
The columns use specially designed surface chemistries and superficially porous particles to deliver precise reversed-phase 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.
Impact on Drug Development
In 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 affect patient safety. The new columns help to overcome these limitations, providing regulatory-ready data and reducing production bottlenecks. This innovation supports the development of safe, effective drug products and helps reduce cost burdens on important new therapeutics.
