Waters UPLC and HDMS Ignite Scientific Ingenuity with New System Solutions at Pittcon 2008

Driven by the vision of scientists worldwide to address challenges that couldn't previously be solved, Waters Corporation today unveiled new innovative solutions at the 59th Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, March 2–6, 2008 in New Orleans that expand the boundaries of its platform technologies.

Leading Waters’ new offerings at Pittcon 2008 is the Waters® PATROL™ UPLC™ Process Analyzer, a real-time liquid chromatography (LC) online process analytical technology (PAT) system; the Waters SYNAPT™ MS system, an upgradeable next-generation quadrupole orthogonal acceleration (oa) time-of-flight (Tof) mass spectrometry (MS) platform; and Waters SDMS™ VP’s Intelligent Procedure Manager (IPM), a workflow software package to guide analysts through laboratory procedures.

“Entering our 50th year of continuous operation, Waters consistently ignites new cycles of innovation working alongside our customers and partners,” said Art Caputo, President of the Waters Division. “In 1963, Dow Chemical approached Waters, at the time a boutique engineering firm, to build a custom on-line refractor for process monitoring applications, which in essences led to the first commercially available LC system. Today, we see history repeating. Just like Dow approached Jim Waters for a custom refractor, it was a leading pharmaceutical manufacturer who approached us at a recent Pittcon meeting to discuss applying UPLC technology to process analysis that led to the development of PATROL UPLC. We can’t wait for the next customer to come into our Pittcon 2008 booth with a problem to solve or a vision to support.”

QC Analysis on the Manufacturing Floor

The new Waters PATROL UPLC Process Analyzer is a real-time online process analytical technology (PAT) system able to detect and quantify complex multiple component manufacturing samples and final product on the production floor.

Designed with the same enabling technology platform as Waters ACQUITY™ Ultra-Performance Liquid Chromatography™ (UPLC) System, the PATROL UPLC Process Analyzer moves existing liquid chromatography (LC) analysis from off-line Quality Control (QC) laboratories directly to the manufacturing stream resulting in significant improvements in production efficiency with real-time analysis, reducing both process cycle times and assuring product quality.

“Waters PATROL UPLC Process Analyzer creates a foundation of confidence by enabling quantifiable, real-time, in-process analysis directly on the manufacturing floor,” said Craig Dobbs, Senior Manager Pharmaceutical Business Operations for the Waters Division. “Liquid chromatography is the ‘Gold Standard’ for analytical testing because of its unmatched selectivity, sensitivity, and dynamic range, combined with its unique ability to resolve and quantify related and unrelated compounds. However, until today LC has not been a viable PAT technique due to unacceptably long analysis times needed for sufficient resolution, lack of efficient automation, and the need for often complex data reduction and analysis. Waters PATROL UPLC Process Analyzer analytical power and speed redefines the PAT equation.”

Waters is currently collaborating with several global pharmaceutical companies to quantify the PATROL UPLC Process Analyzer’s impact on the manufacturing process. A goal of real-time PAT is to produce more product with existing resources compared to a time-consuming, off-line QC process. Early analysis supports that the PATROL UPLC Process Analyzer can enable process recovery increases during major manufacturing steps, virtually eliminating the need for any reprocessing. In general, increase in process recovery results in increase yield, which in turn translates into higher profits per batch.

Future-Proofing MS Laboratories

For the first time at Pittcon, Waters will display its new Waters SYNAPT MS system, a next-generation quadrupole orthogonal acceleration (oa) time-of-flight (Tof) mass spectrometry (MS) platform. SYNAPT MS is a key part of Waters strategy to enhance the quality and productivity of life science and drug discovery and development workflows.

Additionally, the SYNAPT MS system is the only platform which provides a turn-key upgrade pathway to the SYNAPT High Definition MS™ (HDMS™) system, uniquely enabling researchers to analyze samples differentiated by size, shape and charge, as well as mass, ultimately providing new capabilities that can help them meet and exceed their future requirements.

“Confident sample identification, detailed characterization and increased productivity are primary requirements for intelligent mass spectrometry based solutions in key biomedical applications; such as proteomics, metabonomic profiling, biomarker discovery/validation and pharmaceutical R&D,” said Brian W. Smith, Vice President, Mass Spectrometry Operations for the Waters Division. “The new SYNAPT MS meets these demands through application specific system solutions designed to help our customers accelerate and improve the quality of laboratory analysis with the goal of advancing research and reducing time-to-market.”

”A unique aspect of the SYNAPT MS System is that it is ‘HDMS-ready.’ Our customers will be able to upgrade their systems to incorporate the unique High Definition MS capabilities when they require more powerful solutions to meet their future goals, effectively future-proofing their laboratories,” added Smith.

Automates and Integrates Method SOP

Waters Corporation today introduced Waters NuGenesis SDMS Intelligent Procedure Manager, a workflow software package designed to guide a laboratory analyst through a routine, comprehensive method standard operating procedure (SOP) and integrate results with a chromatography data system, such as Waters Empower 2 Chromatography Data Software.

Today, manual or paper-driven guidelines still dominate certain laboratory functions, especially those functions focused on method or analytical SOPs. For example, 1) instrument checks, 2) standards and sample preparation, 3) solvent and mobile phase separation, 4) analyses review, 5) result approval, and 6) final product release are all prone to time inefficiency and data transcription errors because they depend on paper guidelines.

“Expanding off of the industry's most popular and powerful chromatography data measurement software, Waters Empower 2, and able to connect to standard laboratory information management systems, Intelligent Procedure Manager addresses the predominately manual activities required to perform an analytical method or test,” said Phil Kilby, Senior Manager, Informatics Marketing for Waters Division. “Supporting a ‘Right the First Time’ philosophy, Waters estimates potential reduction in cycle time using Intelligent Procedure Manager compared to a traditional paper trail as high as 50 percent, with fewer opportunities for errors.”

From late stage development to final product quality control and lot release, Intelligent Procedure Manager can be equally applied to any lab environment where rigorous adherence to approved test methods and SOPs must be followed, including compliance requirements for cGMP operations. All primary laboratory data and metadata are quickly and easily acquired in electronic form and stored in a secure, 21 CFR Part 11, cGMP-, GLP- compliant database.