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Andy Craze, Senior Director, Informatics BusinessAs an example of an application use for Waters' technology, Craze foresees that biosimilars—identical copies of an original product— represent a growing demand for provision of sufficient analytical and biological evidence between innovator and biosimilar candidates. For biotech organizations challenged to deploy high-resolution analytics across the innovative biotherapeutic or biosimilar development process, Waters designed a progressive informatics platform called UNIFI®, which processes data from advanced and routine analyses to characterize sample compositions, using LC-MS technology. The platform enables a biotech laboratory to comprehensively and routinely acquire, process, and report LC and MS characterization data throughout the biotherapeutic development lifecycle.
“We have integrated our platform with solution kits and workflows, thus providing massive data integrity advantages to customers,” illustrates Craze. “UNIFI’s data mining and comparison capabilities enhance the ability to understand results, and to aggregate and manage data,” he adds. Furthermore, UNIFI provides organizations with the flexibility to deploy UNIFI-based systems within both regulated and non-regulated laboratory environments, while employing high resolution UPLC separations and high performance MS across the entire product lifecycle from discovery to development, and quality control.
UNIFI’s data mining and comparison capabilities enhance the ability to understand results with an unparalleled capability to aggregate and manage data
Since inception, Waters has become attuned to a culture of understanding and addressing client needs. For instance, one of their clients MacroGenics, Inc., a clinical-stage biopharmaceutical company, required a solution to reduce their risk of downstream failure, support their workflow, and provide highly accurate molecular weight information on intact molecules. Deploying the UNIFI platform in their environment helped the client to take their top-down analysis time from 1-3 weeks to 2-3 days. Waters scientists considered every aspect of peptide analysis—from chemistries, instrumentation, software, and methodology to usability, documentation, application support, and remote services—to create fit-for-purpose system solutions for peptide analysis and peptide mapping. As a result, MacroGenics reduced its peptide mapping cycle time from around 3-6 weeks to a single week.
Waters maintains a network of laboratories located around the globe so that customers can interact with the firm’s scientists and prototype implementations of their products. Moreover, Craze understands the need of planning Drug Metabolism and Pharmacokinetics (DMPK) (www.dmpk.waters.com) investments strategically to meet the future demands of laboratories that are expanding as organizations work to reinvigorate their drug product pipelines.
Waters is unique as a technology vendor in the pharmaceutical space, in that it has a very strong applied science base. A significant proportion of its global marketing team has previously worked directly within the pharmaceutical sector - some have even been personally responsible for running major DMPK functions. As such, Waters has a deep understanding of both the science involved in DMPK, the logistics associated with running an efficient operation, and a high degree of awareness towards innovation in the field, and industry dynamics.
Waters Introduces Next-Generation Alliance iS HPLC System Aimed at Reducing Up to 40% of Common Lab Errors
Tuesday, March 21, 2023
• The Waters™ Alliance™ iS High Performance Liquid Chromatography (HPLC) System brings a new level of simplicity and instrument intelligence to QC analyses, helping laboratories eliminate up to 40% of common errors.
• Next-generation HPLC System pairs with Waters Empower™ Chromatography Software and eConnect™ HPLC Columns to help laboratories manage operational risk, mitigate disruptions, and increase overall productivity.
• Easy-to-use touchscreen provides intuitive operation and system health checks together with guided troubleshooting and maintenance to help analysts meet product release deadlines.
• The new Waters Alliance iS HPLC System is an intuitively simple, rugged, and reliable high performance liquid chromatograph designed specifically for the pharmaceutical quality control (QC) laboratory. The instrument makes QC laboratories more efficient by reducing common errors that cause up to 40% of failed sample sets and subsequent out-of-specification results, re-tests and investigations. (Photo: Business Wire)
PHILADELPHIA - Waters Corporation (NYSE:WAT) today introduced Alliance iS, the next-generation intelligent HPLC System, designed to reduce compliance risk by adding new levels of proactive error detection, troubleshooting and ease-of-use. When combined with Waters’ compliance-ready Empower Chromatography Software and eConnect™ HPLC Columns, the Alliance iS High Performance Liquid Chromatography (HPLC) System streamlines the task of making accurate and precise measurements by detecting and eliminating common errors by up to 40%.i In doing so, the Alliance iS HPLC System helps QC laboratories consistently meet quality, safety, compliance, and on-time product delivery goals.
“Today’s QC laboratories are very different than they were 50 years ago when Waters introduced its first commercial HPLC system helping ensure the tens of thousands of prescription drugs on the market are pure, safe, and will work as expected,” said Udit Batra, President & CEO, Waters Corporation. “Our conversations with hundreds of QC managers and bench analysts have yielded a deeper understanding of what they need today from a state-of-the-art HPLC system to help them perform at their best. The Waters Alliance iS HPLC System is ideally suited to address issues such as staff training, error-reduction, risk management, and compliance, helping bring significant productivity and quality improvements to high-volume QC laboratories.”
Based on broad and in-depth customer insights, the Alliance iS HPLC System is thoughtfully designed for the unique needs of the QC laboratory, bringing intuitive simplicity to routine measurements. With visual prompts and alerts delivered via an intuitive touchscreen interface, the system notifies the operator if an improper method is chosen for an application, when a sample vial is missing, when it’s time to refill a solvent bottle, or if it’s time for system maintenance. These are common conditions that when caught early enough, can eliminate system errors that would otherwise degrade the ability of scientists to get needed drugs to patients and ultimately cost a laboratory time and money.
The system also integrates with the cloud-native waters_connect™ System Monitoring Software enabling real-time monitoring of the Alliance iS HPLC System and any other chromatography instruments controlled by Empower Software. Laboratory managers can view the live status of their HPLC instrument fleet from anywhere and at any time to further improve equipment utilization and overall productivity.ii
Waters Alliance iS HPLC System feature highlights include:
• The very latest compliance-ready, industry-standard Empower Chromatography Software with full audit tracking capabilities.
• Advanced instrument touchscreen for guided system operation and maintenance.
• eConnect Column Tag Technology to link column information including injection counts via near-field communication (NFC) technology.
• Automated system diagnostic pre-checks to help meet error reduction key performance indicators (KPIs).
• Tool-free fittings to prevent leaks and provide better chromatography.
Company
Waters Corporation
Management
Andy Craze, Senior Director, Informatics Business
Description
Develops innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance across various industries
