Tillkännagivande • Jun 09
Waters Corporation Launches BioResolve Peptide and GTxResolve Lipid Phenyl-Hexyl+ and C18+ Columns Waters Corporation had announced the launch of the BioResolve Peptide and GTxResolve Lipid Phenyl-Hexyl+ and C18+ Columns, a first-of-its-kind reversed-phase (RP) column platform designed to tackle 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. BioResolve Peptide and GTxResolve Lipid Columns help to overcome these limitations with ready-to-use methods that improve both resolution and speed while fitting into existing workflows. 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. 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 are especially challenging to analyze 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. For LNP and lipid workflows, the charged surface of GTxResolve Columns helps sharpen peaks for ionizable lipids by reducing tailing. Their larger pore size makes it easier for a wide range of lipid molecules to move through the column, improving peak shape and resolving challenging co-elutions. In addition, the superficially porous particle design speeds the movement of molecules through the stationary phase, shortening run times without reducing selectivity. 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. Waters' BioResolve Peptide and GTxResolve Lipid Columns will be available globally beginning June 9, 2026, starting with the 1.6 µm Phenyl-Hexyl+ phase. Tillkännagivande • Jun 04
Waters Corporation Announces FDA 510(k) Clearance Of BD BACTEC FXI Culture System Waters Corporation announced that the BD BACTEC FXI Culture System has received U.S. Food and Drug Administration (FDA) 510(k) clearance. This clearance enables commercialization in the U.S. and provides a new option for laboratories seeking a fully automated blood culture system designed to improve the speed, consistency, and accuracy of sepsis and bloodstream infection diagnostics in modern microbiology laboratories. Clinical study data showed that the BD BACTEC FXI Culture System reduced mean time to detection by approximately three hours (~15%) compared with the previous-generation BD BACTEC FX Blood Culture System (17 hours vs. 20 hours). Faster detection enables earlier pathogen identification and more timely targeted antimicrobial therapy for patients with suspected bloodstream infections and sepsis. Because each hour of delayed sepsis treatment increases mortality by 3.6% to 9.9%, faster diagnostic workflows are critical in acute care settings. The BD BACTEC FXI Culture System features a first-of-its-kind capability in a blood culture platform – an automated gravimetric measurement of individual blood culture vial volume. By objectively confirming blood volume in each vial, the system reduces pre-analytical variability and supports more consistent diagnostics and adherence to recommended collection practices. Designed for high-throughput microbiology labs, the BD BACTEC FXI Culture System fully automates vial loading, unloading, incubation, and detection alerts, with an automated loading capacity of up to 60 vials at a time, 50% more vials than the leading competitor. Available in 480- and 960-vial configurations, the BD BACTEC FXI Culture System delivers scalable efficiency while reducing manual intervention and increasing staff walk-away time. The BD BACTEC FXI Culture System was recently CE marked under the European Union's In Vitro Diagnostic Regulation (IVDR) and licensed by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for availability in Europe and Japan. The BD BACTEC FXI Culture System and BD BACTEC Blood Culture Vials are manufactured by Becton, Dickinson and Company or one of its affiliates or subsidiaries. BD is a trademark of Becton, Dickinson and Company. Waters is a trademark of Waters Corporation or its affiliates. All other marks are the property of their respective owners. The BD Biosciences and BD Diagnostic Solutions businesses have been acquired by Waters Corporation. Becton, Dickinson and Company or one of its affiliates or subsidiaries remains the legal manufacturer of Biosciences and Diagnostic Solutions products until all required regulatory transfers are completed. During this interim period, BD maintains full responsibility for all regulatory obligations of the legal manufacturer. Product information provided here is supplied under BD's regulatory authority. Reported Earnings • May 08
First quarter 2026 earnings released: US$0.88 loss per share (vs US$2.04 profit in 1Q 2025) First quarter 2026 results: US$0.88 loss per share (down from US$2.04 profit in 1Q 2025). Revenue: US$1.27b (up 92% from 1Q 2025). Net loss: US$72.0m (down 159% from profit in 1Q 2025). Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 9.5% growth forecast for the Life Sciences industry in Europe. Tillkännagivande • May 06
Waters Corporation Provides Earnings Guidance for the Second Quarter Ending July 4, 2026 and Full Year Ending December 31, 2026 Waters Corporation provided earnings guidance for the second quarter ending July 4, 2026 and full year ending December 31, 2026. For the quarter, the company expects total revenue for the second quarter of 2026 is expected to be in the range of $1.616 billion to $1.631 billion.
For the year, the company expects total revenue to be to be in the range of $6.405 billion to $6.455 billion on a reported basis. Tillkännagivande • Apr 15
Waters Corporation Debuts Industry-First Extended-Range MALS Detector for UHPLC/UPLC Powering Rapid Characterization of Large Molecules Waters Corporation announced the launch of the Waters omniDAWN Multi-Angle Light Scattering (MALS) Photometer, part of the Wyatt Technology Portfolio. Featuring 18 angles of detection, the omniDAWN Photometer is the first extended-range MALS detector for Ultra High Performance Liquid Chromatography (UHPLC) and Ultra Performance Liquid Chromatography (UPLC) workflows, delivering absolute molar mass and size measurements without compromising resolution or throughput. The omniDAWN MALS Photometer extends UPLC-compatible sizing ten-fold, from approximately 50 to 500 nm in radius, enabling reliable characterization of larger, more complex analytes such as protein aggregates, viral vectors, lipid nanoparticles (LNPs), and advanced materials. Because it provides absolute molar mass and size, the omniDAWN Photometer reduces reliance on column calibration standards and supports faster results and more confident comparisons, streamlining work across biosimilarity studies, antibody-drug conjugate (ADC) characterization, and viral vector analytics. Integrating seamlessly with Waters UPLC Systems and columns, the omniDAWN Photometer eliminates traditional trade-offs between dispersion, robustness, and analytical performance, delivering a complete solution for multi-attribute characterization with improved usability compared to micro-volume MALS approaches. When paired with UHPLC or UPLC Systems, the omniDAWN Photometer supports run times up to four times faster than conventional HPLC workflows, while reducing sample consumption by 30–50% and solvent use by approximately 40%. Its low dispersion design preserves resolution and sensitivity, while delivering high-quality data across complex samples. Sharper separations enhance the detection of low-level species, helping scientists distinguish monomer, aggregates, and fragments with greater clarity, supporting informed decision-making across discovery, development, and quality workflows. The omniDAWN Photometer is powered by ASTRA Software, built on more than 40 years of light scattering innovation. By integrating MALS with ultraviolet (UV) and refractive index (RI) detection, ASTRA Software enables comprehensive analysis of size, composition, and heterogeneity in a single run, with dedicated workflows for ADCs, LNPs, and viral vectors. The platform is 21 CFR Part 11 and EU Annex 11 compliant and will be compatible with Waters Empower Software later this year. The Waters omniDAWN MALS Photometer will be available globally in summer 2026. 
