FEATURED ARTICLES

• Modernizing Compendial SEC Methods For Biotherapeutics

  Explore the advantages of a bio-inert HPLC system through the migration and modernization of a compendial SEC method outlined in the United States Pharmacopeia (USP) General Chapter <129>.

• Deploying A Modern HPLC For Biopharma Analysis In QC Environments

  Explore findings from a study evaluating the performance of a modern HPLC system in comparison to a legacy system in a routine QC testing environment for 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 MaxPeak HPS Technology enhances the analysis of intact proteins, peptides, nucleotides, glycans, and cell culture, 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informatics from Waters Corporation can help you eliminate the issues associated with older technology and outdated manual processes.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 Their 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 active pharmaceutical ingredients 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.

• A Versatile Application For Rapid Mass Confirmation And Purity Assessment Of Biotherapeutics

  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.

• Transferring N-Glycan HILIC Separations Between UPLC And HPLC

  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.

• Improving Released N-glycan Analysis In Biotherapeutic Development Using Premier Solution With HPS Technology

  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.

• Method Migration Of Size-Exclusion And Ion- Exchange Methods For Monoclonal Antibody Analysis

  Discover how combining this system with modern UHPLC columns could make data more accurately interpreted through greater efficiency, selectivity, and enhanced resolution.

• Rapid Size Variant Analysis of Monoclonal Antibodies Using SEC Columns

  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.

• Building Quality Into Everything We Do – From A To Z

  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.

• ACQUITY And XBridge Premier Protein SEC 250 Å Columns: A New Benchmark In Inert SEC Column Design

  We demonstrate the performance of a new column technology designed to provide a holistic solution to the problems of undesired secondary interactions in SEC.

• Innovation Standardized – Bioseparation Methods For Biotherapeutics

  Discover the most impactful standards in liquid chromatography (LC) for biotherapeutics. The standardizations include methods, columns, standards, and robustness.

• 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.

• Improvements In Recovery, Reproducibility, And Matrix Effects With A Novel Solid Phase Extraction Sorbent

  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.

• Selecting A Reversed-Phase Column For The Peptide Mapping Analysis Of A Biotherapeutic Protein

  In this study we review reversed-phase (RP) column selection considerations for peptide mapping applied to the routine characterization and analysis of biotherapeutic proteins.

• BEH C₁₈ Batch-To-Batch Robustness For The Analysis Of Rosuvastatin And Impurities

  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.

• A Look At Column Reproducibility: Analysis Of Endogenous Steroid Hormones In Serum

  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.

• Increasing Chromatographic Performance Of Acidic Peptides In RPLC-MS-based Assays

  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.

• Successfully Transfer Methods While Using Different Vendor’s Equipment

  Successfully replicates methods, producing equivalent chromatographic separation and analytical results generated by the method to the results obtained on the comparable LC systems.

• Examining Column Reproducibility During Method Development In Clinical Labs

  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.

• Perform HPLC Method Transfer Between Analytical Testing Equipment

  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.

• Risk-Based Approach Supports Migration Of Legacy Methods For Eurofins BPT Toronto

  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.

• Overcoming Method Transfer Challenges

  Although development and quality control labs might be slow to replace existing technologies, modernization can benefit legacy methods and future development activities.