FEATURED ARTICLES

• Advancing QC Efficiency With SEC-MALS System And Empower Software

  Discover how integration transforms lab workflows to enhance molecular characterization, streamline data management, and ensure compliance for superior data integrity and operational efficiency.

• Complementing Routine Peptide Monitoring

  Discover how to enhance your peptide analysis by integrating UV and mass spectral data into a single, streamlined workflow to boost data confidence and lab efficiency.

• LC-UV-Based Synthetic Peptide Impurity Tracking And Reporting

  Explore a UPLC-UV method using Empower 3 Software to assess synthetic peptide purity. Learn how integrated tools streamline impurity tracking, data reporting, and compliance in peptide analysis workflows.

• Characterization And Impurity Profiling Of Combined Amylin And GLP-1 Analogs

  GLP-1 receptor agonists are transforming diabetes and weight loss treatment. Discover how to enable precise impurity analysis and characterization of complex, fatty acid-modified peptide therapeutics.

• Identification Of GLP-1 Analog Oligomeric States Using SEC-MALS

  Discover how SEC-MALS enables precise characterization of GLP-1a therapeutics to ensure formulation integrity and enhance safety, efficacy, and regulatory confidence.

• Development Of A High Sensitivity SPE-LC-MS/MS Assay

  Achieve ultra-sensitive glucagon quantification with ionKey/MS, μElution SPE, and advanced MS fragmentation to deliver low LOD, reduced sample loss, and enhanced confidence in results.

• Quantification Of Exenatide Using Xevo TQD

  Discover a highly sensitive and reliable LC-MS/MS method for quantifying exenatide in plasma that is powered by advanced sample prep and optimized column chemistries.

• Application Of LC-UV/MS Workflows To Increase Efficiency

  Discover how LC-UV/MS workflows help overcome analytical challenges in GLP-1 analog development to streamline impurity identification and boost lab efficiency in research.

• Accelerating Method Development And Manufacturing Of GLP-1 Analogs

  Explore a streamlined LC-UV/MS workflow that empowers labs to meet rising GLP-1 drug demand with faster, more informed decisions that enhance compliance and impurity detection efficiency.

• Comprehensive Workflow For The Quantification Of Peptides And Proteins

  Biologics are transforming medicine, with semaglutide leading the way. Discover how an automated LC-MS/MS workflow enables high-sensitivity quantification of peptides in plasma.

• Temperature Dependence On Reversed-Phase Separations

  Column temperature critically affects the reversed-phase separation of fatty acid-modified GLP-1 RAs and impurities. Learn how precise control enhances resolution and reproducibility.

• Column Selection For RPLC-UV Impurity Analysis

  Explore the performance of four column chemistries for RPLC-UV impurity analysis of liraglutide and semaglutide, which offers practical guidance for method development in peptide-based therapeutics.

• UPLC-MS/MS Determination Of GLP-1 Analogue

  Discover a robust, evaporation-free method for analyzing liraglutide in human plasma using LC-MS/MS to ensure high sensitivity, reproducibility, and improved analyte recovery.

• Quantification Of Semaglutide With A Reliable Analytical Method

  Explore a validated LC-MS/MS method for precise Semaglutide quantification in plasma, which features enhanced sensitivity, peak definition, and reproducibility using innovative technologies.

• Developing A Quantitative Surrogate Peptide Assay

  Discover a streamlined LC-MS/MS workflow for Fc-containing therapeutics like dulaglutide to enable precise quantification with LLOQ as low as 1 ng/mL through automated, efficient assay development.

• Development Of An Effective LC-MS/MS Cleaning Validation Method

  Gain insight into a robust LC-MS/MS method for quantifying therapeutic peptides that supports contamination control and cleaning validation to ensure product safety and integrity.

• Bioanalytical Quantification Of A Biotherapeutic Peptide

  Discover a sensitive, selective, and robust LC-MS method for quantifying semaglutide in plasma with advanced sample preparation and detection technologies for accurate results in bioanalytical research.

• Improved GLP-1 Receptor Agonist Peptide Recovery

  Discover how an innovative technology enhances LC-MS analysis of GLP-1 receptor agonists by minimizing peptide loss and improving assay sensitivity and consistency.

• Development Of Separation Methods For GLP-1 Synthetic Peptides

  Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

• Improving Consumer Safety Through Innovative Science

  Liquid chromatography revolutionizes science with precision. Discover a technology that leads the charge in enhancing HPLC performance for breakthroughs in health, safety, and environmental research.

• Leveraging A Modern HPLC System For Peptide Drug Substances Analysis

  This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.

• The Role Of Change Management In Supporting Innovation In Pharma

  Learn in detail about the impact of change management on the pharmaceutical industry and how it ensures innovations and improvements are managed effectively.

• Improving Chromatographic Separations Of Biopharmaceuticals

  We demonstrate how surface chemistry technology enhances the analysis of intact proteins, peptides, nucleotides, glycans, and cell cultures, addressing evolving biopharmaceutical therapeutic needs.

• Scaling Up Your Methods With USP <621> - Part 2: Hardware

  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.

• Scaling Up Your Methods With USP <621> - Part 1: Chemistry

  Explore the latest updates to the USP <621> guidelines that involve changes to the allowable modifications to gradient methods and updates to system suitability parameters.

• Scaling Up Your Methods with USP <621> - Part 3: Software

  Learn how Empower Software addresses modifications to certain calculations and maintains relevant naming conventions and calculations to help customers update SOPs to prevent disruption to operations.

• A Practical Guide To Liquid Chromatography (LC) Method Adjustment

  Are you looking to update a validated liquid chromatography method? This guide offers a step-by-step approach to adjusting your methods that can help you achieve your goals and save time in the process.

• How Modern Technology Can Help Mitigate Risk And Failure In QC Labs

  Discover how analytical instrumentation, chemistries, and purpose-built informatics from Waters Corporation can help you eliminate the issues associated with older technology and outdated manual processes.

• Driving Efficiency In QC Labs

  Here, we examine the cause and impact of common errors in Quality Control (QC) labs, the strategy for reducing those errors with an intuitive chromatography system, and more.

• Hydrophilic Interaction Liquid Chromatography (HILIC) Method Migration

  Explore results from an experiment analyzing the USP monograph for cetirizine hydrochloride assay and organic impurities on two legacy HPLC systems and migrating them to the Alliance™ iS HPLC System.

• Mitigate Human Error And Improve Performance In Pharma QC

  Gain insight into how the Quality Control team at Almac Sciences developed processes and strategies to help ensure a high quality of safe and effective products while also maximizing efficiency.

• CDMO Grows 20% From Laboratory Instrumentation Provider Partnership

  A partnership facilitated capacity, efficiency, and compliance of pharmaceutical manufacturing and analytical service increases for a prominent CDMO.

• Simultaneous Determination Of Two APIs And Related Compounds By HPLC

  Discover a single HPLC method that can replace several separate methods for the analysis of the assays and organic impurities of APIs naphazoline hydrochloride and pheniramine maleate.

• Improved Chlorhexidine Carryover Performance Using A Modern System

  Carryover performance was assessed across HPLC systems using a scaled method based on the USP monograph for chlorhexidine hydrochloride organic impurities. Explore results and mitigation strategies.

• Method Migration Of The USP Ibuprofen Assay And Organic Impurities Method

  An isocratic USP monograph for ibuprofen and related organic impurities was used to assess a method migration between HPLC systems. Explore results that demonstrate the ability to migrate methods.

• Achieving Method Modernization With Chromatographic Gradient Allowances

  Learn how the gradient method allowances described in USP General Chapter <621> Chromatography, combined with a HPLC system, were employed for the USP monograph separation of abacavir sulfate.

• Multi-Attribute Methods For Biopharmaceutical Analysis

  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.

• MAM Analysis: Avoiding Assay Traps

  Multi-Attribute Method analysis using liquid chromatography – mass spectrometry has emerged as a valuable tool for drug discovery, development, process monitoring and quality control.

• MAM Solutions For Process, Product Control Of Biotherapeutic Proteins

  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.

• Confident O-Glycosylation Site Identification For ENBREL (etanercept)

  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.

• Evaluating A Flexible LC Platform

  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.

• MAM For Biopharmaceutical Analysis

  This notebook from the Biopharmaceutical Scientific Operations Team at Waters illustrates key attribute monitoring workflows to improve and streamline MAM analysis of biotherapeutic proteins.

• Multi-Attribute Method Analysis: Moving Toward Mainstream

  Employing the Multi-Attribute Method based on liquid chromatography-mass spectrometry analysis represents a critical advancement in evaluating the complexity of biotherapeutic molecules.

• Method Transfer Of A USP Organic Impurities Method To An Arc HPLC

  Learn about a global interlaboratory method transfer study of a USP impurities method that was conducted at eight participating sites.

• Dwell Volume And Extra-Column Volume: What Are They And How Do They Impact Method Transfer?

  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.

• Streamline Method Validation In Pharmaceutical Product Development

  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.

• Method Development of Ten Antibiotic Compounds Using A Systematic Screening Protocol

  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.

• Sequencing Of Synthetic Oligonucleotides And Their Impurities

  We demonstrate an automated, compliance-ready liquid chromatography-mass spectrometry (LC-MS) workflow for sequence confirmation of oligonucleotides and their impurities.

• In-Process Media Monitoring Using LC-MS And Automated High Throughput Microbioreactor Systems

  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.

• Automating Rapid High-Throughput LC-MS mAb Subunit Screening

  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.