FEATURED ARTICLES

• Multi-Attribute Method Analysis: Avoiding Potential Traps During Assay Development And Deployment

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

• Multi Attribute Method (MAM) Solutions For Process And 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.

• Multi-Attribute Methods For Biopharmaceutical Analysis

  This notebook compiles several recent application notes generated by the Biopharmaceutical Scientific Operations Team at Waters. They illustrate key attribute monitoring workflows that have been developed 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.

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

  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.

• 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 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.

• 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.

• How Dwell Volume And Extra-Column Volume 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.

• Achieving Equivalent Results When Transferring Methods While Using Different Vendor’s Equipment

  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.

• 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.

• How To 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.

• Rapid Mass Confirmation And Purity Analysis Of Biotherapeutics

  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.

• It's About Time! Automate Biomolecule LC-MS Spectral Deconvolution

  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.

• Improving Recovery And Quantitation Of Oligonucleotide Impurities

  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.

• Data Processing For Mass Confirmation, Impurities Analysis Of Oligos

  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.

• Embracing LC-MS Analytical Techniques Into Regulated Laboratories

  We address the additional compliance challenge in biopharma of the requirement of complex analytical instruments that are not traditionally used in highly regulated labs.

• Direct LC-MS Characterization Of Glycoform Distribution And Low Molecular Weight Impurities In mAb Process From Ambr® 15 Bioreactors

  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.

• Safeguard HPLC Data Quality With Planned Performance Maintenance

  Learn how to safeguard your data quality by ensuring your HPLC instrument remains consistently in peak condition.

• How Can Contract Organizations Bridge The Talent Gap In Biopharma?

  Instrument vendors can play a critical role in decreasing the training timeline for new and even existing staff at a contract organization.

• How One Biotech Leveraged Advanced Preclinical Studies

  BriOri Biotech used cutting-edge technology to achieve the sensitivity and reduced carryover needed for analysis of reformulated COX-2 inhibitor.

• Contract Testing Lab Quickly Responds To Increased Customer Requests For Nitrosamine Services

  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.

• Learn How Compliance-Ready LC-MS Workflows for Oligonucleotides Can Expand your Analytical Services Portfolio

  CMO invests in solution to ensure data integrity and meet regulatory requirements as they expand their oligonucleotide manufacturing and analysis services.

• A&M STABTEST Expands Service Offerings In Protein And Oligonucleotide Analysis With LC-MS System

  CRO upgrades systems to provide regulatory compliance for large-molecule protein analysis, expanding their oligonucleotides capabilities.

• Future-Proofing Peptide MAM By Ensuring Scalability And Deployment

  Knowledge gained through liquid-chromotography-mass spectometry can be transformed into single multiplexed assays for monitoring attributes across development, manufacturing, and release.

• Improving Routine Biotherapeutic Analysis: Some Things Work Better Together

  Taking analytical workflow capabilities further is necessary to realize the full vision of many companies and regulators to enable direct measurement of biotherapeutic attributes.

• Attribute Monitoring Workflows: Connecting Molecular Attributes To Product And Process Knowledge

  For biopharmaceutical organizations who need the power and performance of LC-MS for routine screening and MAM, we have designed the first SmartMS-enabled biopharma LC-MS solution. Learn more about connecting molecular attributes to product and process knowledge using the BioAccord System.