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Waters Introduces Regulated Bioanalysis System Solution Facilitating Consistent and Compliant Workflows

Waters
31 May 2011
bridget bridget
Laboratory Director

Product news

Waters Corporation today introduced the new Waters® Regulated Bioanalysis System Solution, a breakthrough LC/MS/MS system for bioanalysis that combines the latest in sample preparation, UltraPerformance LC® (UPLC®) separations technology and chemistries, tandem quadrupole mass spectrometry, and the UNIFI™ Scientific Information System. This first-of-its-kind, single-vendor system solution is tailor-made for bioanalytical laboratories and generates quantitative results quickly and accurately, maximizes uptime, reduces cost per sample, and helps bring projects to completion more quickly.

Designed first and foremost with the needs of the bioanalytical scientist in mind, the Waters Regulated Bioanalysis System Solution ties together all the necessary components for streamlined bioanalysis of small molecule drugs and biotherapeutics.

Waters intends to ship the first units of the Regulated Bioanalysis System Solution with UNIFI in the fourth quarter of 2011.

From sample preparation to final report, the Regulated Bioanalysis System Solution includes:

• Oasis® and Ostro™ Sample Preparation Chemistries – delivers the cleanest extracts and minimizes matrix effects
• ACQUITY UPLC® I-Class System – Waters lowest dispersion and lowest carryover UPLC system delivers maximum separations power to ensure resolution from the matrix
• ACQUITY UPLC Columns – a broad range of chemistries to maximize selectivity
• Xevo®TQ-S – featuring unique off-axis ion source technology that delivers unprecedented levels of sensitivity and selectivity for the quantitation of trace levels of drugs and their metabolites in the most complex samples
• UNIFI Scientific Information Management System – represents a single platform for LC and MS operational control and for bioanalysis data processing, visualization, reporting and the configuring of G(x)P compliance tools such as electronic signatures and audit trails. Features embedded tools that simplify system qualification and software validation.
• Unique bioanalysis workflows with integrated tools such as RADAR that accelerate analytical methods development by giving scientists MRM and full scan MS data in one experiment
• Waters post-sale service and support expertise, including automated system qualification and validation services

Today’s bioanalysts must often piece together their own multi-vendor system which requires them to trade off data quality or productivity in order to meet regulatory requirements. The resulting compromises have prevented them from reaching their full potential.

Waters Regulated Bioanalytical System Solution is powered by UNIFI – Waters next generation informatics software. UNIFI software is a one-of-kind single platform for controlling all LC and MS operations, processing LC and MS data, and generating IQ/OQ/PQ reports, maintaining electronic maintenance logs and signatures. Its user interface is available in multiple languages so that scientists can work with the software in their own language. And, it easily imports from and exports data to LIMS systems ensuring data integrity. UNIFI's server based architecture enables workgroup deployment to maximize productivity and data integrity, while reducing validation overhead. The software features intuitive, streamlined and secure workflows specifically tailored for the bioanalyst.

Waters Regulated Bioanalytical System Solution brings laboratories these important benefits.

• Comprehensively meet the converging needs of scientists, analysts, managers, QA and IT professionals
• Measure matrix effects, identify and understand the impact of metabolites with the industry’s most sophisticated bioanalytical toolset
• Facilitates compliance with increasing regulatory demands, such as ISR, MIST, 21 CFR Part 11, and G(x)P
• Improved ability to adapt to changing scientific, business, regulatory, and industry challenges
• Develop robust methods faster with the sensitivity to meet assay requirements
• Maximize uptime and minimize cost per sample
• Improved ability to meet project deadlines; strengthen client relationships

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AutosamplersAutosamplers are automated sample loaders used with a number of separation and analytical techniques. HPLC autosamplers use automated partial or full-loop injection systems and place samples in vials or microplates for analysis. Autosamplers can also be used for elemental analysis. Features to consider include repeatability, syringe capacity, footprint and temperature controls.  UHPLC and HPLCHigh performance liquid chromatography (HPLC) and ultra high performance liquid chromatography (UHPLC), also known as UPLC, are analytical techniques used to separate, identify and quantitate components of complex mixtures including biological samples such as proteins and lipids as well as chemical mixtures of pesticides, drugs and oils. Both techniques are liquid chromatographic methods but differ by operating pressures (HPLC < 6000 psi < UHPLC ). Components of HPLC and UHPLC systems include columns, detectors, pumps, autosamplers and column heaters. Explore a range of UHPLC and HPLC columns for your specific sample needs including reverse phase, normal phase, ion exchange, HILIC, ion exclusion and size exclusion columns. For more specialized HPLC, explore FPLC, countercurrent LC and simulated moving bed systems. Find the best UHPLC and HPLC equipment in our peer reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Sample PreparationSample preparation can improve the quality and speed of separation techniques. Products to assist sample preparation include filtration equipment, evaporators, membranes and sieves.LC-MSLC-MS (liquid chromatography-mass spectrometry) systems and equipment are used for separation and quantitative analysis of complex mixtures, combining liquid chromatography and mass spectrometry. Quantify proteins, contaminants, pesticides or screen for drug metabolites with a high level of sensitivity. LC-MS systems and equipment include reverse phase, normal phase and specialized columns integrated with various MS detectors such as time-of-flight (TOF), quadrupole, orbitrap or ion trap mass analyzers. LC-MS/MS instruments equipped with a qTOF or triple quadrupole analyzer give greater sensitivity and resolving power to your analysis. Find the best LC-MS equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.LIMSLIMS (Laboratory Information Management System) is an informatics software system used to improve the quality assurance and quality control (QA / QC) of data management. LIMS can be a standard for common lab workflows, such as commercial off the shelf systems (COTS), or customized for more specialized lab use. Systems are available for mainframe computers or PC.Preparative ChromatographyPreparative chromatography equipment is used for purification purposes, separating and collecting compounds eluted from a mixture which can then be subsequently used for further purposes. This can be done in large quantities or small. Preparative chromatography systems are usually low to medium pressure liquid chromatographs that are semi-automated. Explore a range of preparative columns and fraction collectors. Find the best preparative chromatography equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Biopharmaceutical AdvancesBiopharmaceutical advances follow the development of pharmaceuticals derived from biotechnology, also known as biotechnology medicines. Biopharmaceuticals may be produced from cell lines, plants, or microbial cells. Important considerations of biopharmaceutical use include application, cost, production process and purification.

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Waters Introduces Regulated Bioanalysis System Solution Facilitating Consistent and Compliant Workflows