
ABOUT WATERS CORPORATION
Waters Corporation unlocks the potential of science through analytical measurement technology, deep scientific expertise, and reliable insights to enhance human health and well-being. As a global leader in analytical instruments, consumables, and software, Waters has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,800 employees worldwide, Waters operates in 35 countries, including 14 manufacturing facilities, and with products available in more than 100 countries.
FEATURED ARTICLES
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Learn about a partnership that facilitated increases in the capacity, efficiency, and compliance of pharmaceutical manufacturing and analytical services for a prominent contract development and manufacturing organization (CDMO).
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Explore three perspectives on the capabilities and adoption of MAM workflows within the biopharmaceutical industry in addition to MAM resources for process and product control of biotherapeutic proteins.
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Multi-Attribute Method analysis using liquid chromatography – mass spectrometry has emerged as a valuable tool for drug discovery, development, process monitoring and quality control.
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With industry-leading scientific expertise and customer support, we have pioneered solutions to some of the most pressing challenges facing customers interested in adopting MAM into their organizations.
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Explore the utility of electron capture dissociation (ECD) on the SELECT SERIES Cyclic IMS instrument for unambiguous assignment of glycosylation site locations for 11 Oglycopeptide species of ENBREL.
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Learn about a premier system offering a flexible LC platform that can be broadly deployed across labs to support the analytical needs in the development and manufacturing of biotherapeutics.
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This notebook from the Biopharmaceutical Scientific Operations Team at Waters illustrates key attribute monitoring workflows to improve and streamline MAM analysis of biotherapeutic proteins.
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Employing the Multi-Attribute Method based on liquid chromatography-mass spectrometry analysis represents a critical advancement in evaluating the complexity of biotherapeutic molecules.
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Learn about modifications to certain calculations and how they will be addressed using our software along with how relevant naming conventions and calculations will be maintained to help customers.
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Learn about the hardware changes that allow for scaling and modernization of chromatographic methods and how mismatching particle size and liquid chromatographic systems can result in poor performance.
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Explore the revised USP <621> guidelines that are scheduled to take effect in the near future. These critical updates involve changes to the allowable modifications to gradients.
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Learn about a global interlaboratory method transfer study of a USP impurities method that was conducted at eight participating sites.
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Understand how system factors like dwell volume and extra-column volume contribute to method performance across labs and how this knowledge can increase the success of method transfer.
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Method validation is a time-consuming activity prone to human error. Find out how a method validation manager can provide a single, comprehensive solution for your validation activities.
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Effective method development of LC and LCMS methods typically involve highly experienced scientists with a wealth of knowledge that has been handed down throughout their organization. For some particularly challenging and complex mixtures this experience may not be enough. Learn how Waters leveraged a generic systematic protocol to separate a variety of APIs in a single run.
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We demonstrate an automated, compliance-ready liquid chromatography-mass spectrometry (LC-MS) workflow for sequence confirmation of oligonucleotides and their impurities.
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Explore a comprehensive LC-MS methodology, workflow, and batch analysis software that allows bioprocessing engineers to quickly and easily run and process large number of samples.
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We present a fully automated workflow for sample preparation and LC-MS analysis of mAbs obtained directly from complex samples such as spent cell culture media including host cell protein.
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We explore a streamlined integrated workflow for data acquisition, processing and reporting of deconvoluted mass data for biotherapeutics, deployable in regulated and non-regulated environments.
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We demonstrate that comparable chromatographic profiles and relative quantitation can be achieved with the larger particle size column at HPLC-compatible pressures, albeit with an increase in sample load, mobile phase use, and most importantly, analysis time.
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Explore how we improved releasing N-glycan analysis in biotherapeutic development, which can help develop robust and unbiased glycan assays for biotherapeutic development, manufacture, and release.
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Discover how combining this system with modern UHPLC columns could make data more accurately interpreted through greater efficiency, selectivity, and enhanced resolution.
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This study examines technological advancements in both the column hardware and packed particle chemistry of solution that provides extended column lifetimes when using physiological pH mobile phases.
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By having better control over our manufacturing processes we are able to minimize the risk of out-of-specification intermediates all the way through to final products.
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We demonstrate the performance of a new column technology designed to provide a holistic solution to the problems of undesired secondary interactions in SEC.
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Discover the most impactful standards in liquid chromatography (LC) for biotherapeutics. The standardizations include methods, columns, standards, and robustness.
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Performance Stability Of CORTECS 2.7 μm Columns Following Repeated Injections Of Precipitated Plasma
We review a column made using optimally packed solid-core particles. These columns are designed to tolerate repeated injections of minimally processed samples, while maintaining assay performance.
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In this study we review a successful next generation reversed solid-phase extraction (SPE) product that produces cleaner extracts with simpler protocols and faster processing time.
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In this study we review reversed-phase (RP) column selection considerations for peptide mapping applied to the routine characterization and analysis of biotherapeutic proteins.
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The main goal of this study is to investigate the long-term batch-to-batch reproducibility of 10 different lots of XBridge BEH C18 Columns. Discover the findings of this study.
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Having reproducible columns is critical for the success of batch to batch testing of stationary phases, as well as ensuring lifelong performance for the assay.
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We demonstrate how to increase productivity in the lab and mitigate risk through increased reproducibility, recovery, and robustness of assays performed in the development and manufacturing of biopharmaceutical drug products.
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We demonstrate method transfer and migration between instruments that successfully replicates methods, producing equivalent chromatographic separation and analytical results generated by the method to the results obtained on the comparable LC systems.
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In this study demonstrates how the HSS T3 stationary phase is a reliable stationary phase, as three batches made over a five-year span provide comparable results.
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It is essential for the analytical laboratories to successfully transfer analytical methods. We present a transfer of the HPLC method for related substances analysis of metoclopramide HCl.
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Eurofins Bio-Pharma Product Testing applied a modern, risk-based approach to method migration and was able to understand the impact of introducing state-of-the-art technology for their legacy methods.
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Although development and quality control labs might be slow to replace existing technologies, modernization can benefit legacy methods and future development activities.
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Here, we report the development of an application that streamlines LC-MS data acquisition, data intact mass processing and reporting of results suitable for a compliance-ready environment.
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We detail the approach we’ve taken to not only speed up the processing of macromolecule electrospray MS data but to build smarter deconvolution workflows.
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An alternative to conventional stainless-steel columns and LC systems having a metal-containing flow path for UV-based analysis of oligonucleotides to address challenges associated with nonspecific adsorption.
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We demonstrate an automated, compliance-ready LC-MS workflow for intact mass confirmation and purity analysis of synthetic oligonucleotides including siRNA and large single guide RNA oligonucleotides.
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We address the additional compliance challenge in biopharma of the requirement of complex analytical instruments that are not traditionally used in highly regulated labs.
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We demonstrate a streamlined and robust mAb product monitoring method that is high throughput capable and has the potential to be a fully automated platform for mid-process intraday monitoring of CQAs.
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Learn how to safeguard your data quality by ensuring your HPLC instrument remains consistently in peak condition.
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Instrument vendors can play a critical role in decreasing the training timeline for new and even existing staff at a contract organization.
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BriOri Biotech used cutting-edge technology to achieve the sensitivity and reduced carryover needed for analysis of reformulated COX-2 inhibitor.
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A mass spectrometer solution accompanied with a security software enabled Pharma & Tech to develop their nitrosamine impurity testing services in less than two months, as they responded to evolving global regulatory guidelines.
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CMO invests in solution to ensure data integrity and meet regulatory requirements as they expand their oligonucleotide manufacturing and analysis services.
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CRO upgrades systems to provide regulatory compliance for large-molecule protein analysis, expanding their oligonucleotides capabilities.
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Knowledge gained through liquid-chromotography-mass spectometry can be transformed into single multiplexed assays for monitoring attributes across development, manufacturing, and release.
CONTACT INFORMATION
BROCHURES AND DATASHEETS
- FlexMETHODS+ Method Migration Service
- Arc HPLC
- Mass Detection For Undergraduates
- Compliance And Validation Services For Waters Informatics Solutions
- Control Your Bioprocess Development: Faster Decisions With Quality Data
- Adopting Enabling Informatics Technologies To Drive Digital Transformation And Data Integrity
- Metrology Teams Collaborating With Waters
- How Are You Addressing Site Expansions While Meeting Important Project Deadlines?
- Increase Employee Retention And Compliance By Investing In Quality Training From Waters
- Generate Revenue And Attract New Projects While Conserving Capital
- Four Keys To Great Bioanalytical Methods
- MaxPeak Premier Columns For Peptide Analysis
- Eliminate Doubt With Chemistry Technical Services
- MaxPeak Premier For Glycan Analysis
- LC And LC-MS Chemistry Consumables For Bioseparations
- MaxPeak Premier Columns For Intact And Subunit Protein Analysis
- MaxPeak Premier Columns For Protein SEC Analysis
- Waters Columns Calculator
- Solutions For Aggregate And Fragment Analyses
- Is NSA Sabotaging Your Lab's Productivity
- Waters Liquid Chromatography And LC-MS Solutions
- ACQUITY Premier Analytical Solution
- FlexMETHODS+ Method Migration Service
- Comprehensive Support For Regulated Laboratories With FlexCHOICE Service Coverage
- Protect Your Lab Instruments From Expected Downtime With FlexCHOICE Service Coverage