Application Notes: LC
Method Optimization of Purity Analysis of an Fc-Fusion Protein by Reversed-Phase HPLC
For Fc Fusion proteins a reversed-phase LC analytical method is used for either extended characterization and identification for impurities or as a simple purity method.
Superior Sample Capacity for Basic Compounds
Loading capacity and peak shape of basic pharmaceuticals were compared on the Agilent InfinityLab Poroshell 120 CS-C18 and a traditional C18 column with formic acid.
Purity Analysis for Intact Monoclonal Antibodies and Fragments
Intact reversed-phase LC method is implemented for a simple yet high-resolution analytical technique that can be used for the purity analysis of monoclonal antibodies.
From Data Integrity Regulations to Pharma 4.0
This white paper provides a vendor’s perspective on recent trends in regulations and the potential future direction for the industry referred to as “Pharma 4.0”.
Chromatography Optimization for Intact Mass Analysis of Monoclonal Antibodies
Analyzing diverse method parameters, such as temperature, gradient program, and flow rates for optimization of intact mass applications when using bioZen WidePore C4.
Using pH as a Method Development Tool
The value of a wide range of pH compatibility is explored. A pesticide mixture shows how eluent pH affects analyte retention for acids, bases, and neutrals.
Method Development of C18 Columns at Low pH
The unique selectivity of four Agilent InfinityLab Poroshell 120 C18 columns is shown with veterinary drugs using a simple formic acid and acetonitrile gradient.
Backup vs. Archive: Why You Need Both
Using Empower CDS and NuGenesis LMS to develop an archive strategy that reduces backup and recovery times and removes manual intervention is demonstrated.
Durable Data for Non-IT
Companies can seek outside help for backup and restore, disaster recovery, and system administration, but responsibility for regulated data remains with the company.
VITAQUEST Streamlines Lab Operations with NuGenesis LMS
VITAQUEST, a contract manufacturer of dietary supplements, used NuGenesis LMS to automate its workflows, improve lab efficiency, and reduce the risk for data errors.
Empower Cloud Streamlines Pharmaceutical Operations
This study shows how coupling Waters’ Empower CDS with cloud technology allowed a pharmaceutical company to streamline its global operations and connect each of its labs.
Role of Empower CDS in Electronic Record Regulation Compliance
This white paper explains the 21 CFR Part 11 and EU EudraLex Annex 11 compliance readiness of Waters Empower Software for the regulated scientific laboratory.
Managing Empower Data with NuGenesis LMS
This case study demonstrates the advantages of pairing Empower CDS with NuGenesis LMS to improve the availability of your CDS data and maximize its effectiveness.
CRO Increases Advantage by Implementing Empower CDS
A&M Stabtest, an independent CRO in the pharmaceutical industry, reduced time-consuming and error-prone manual steps in the chromatographic testing process.
CDMO Advances Data Integrity and Lab Productivity
An investment in Waters NuGenesis LMS helped a global pharmaceutical CDMO meet demands for data integrity regulatory compliance and laboratory management needs.
Method Lifecycle Management Drives Development at CDMO
This study demonstrates Waters ACQUITY UPLC with PDA/QDa technology and Empower Software were integral to successful method lifecycle management at Hovione, a global CDMO.
Importance of Business Continuity in Today’s Lab
Companies can reduce the fallout of a disaster via a business continuity plan with appropriate hardware and software, including Waters Empower BC LAC/E with SecureSync.
Halo Acetic Acid Identification by Ion–Exclusion
Accurate detection of HAA’s is paramount for the prevention of over oxidation, while still managing enough water sanitation to eliminate water borne pathogens.
High Throughput DAR Determination of Brentuximab Vedotin
YMC’s latest HIC column is used to analyse the DAR of Brentuximab Vedotin allowing higher flow rates and shorter run times thanks to the pressure resistant particle.
The Right HIC Column For Each Separation
YMC’s HIC columns, BioPro HIC HT, and BioPro HIC BF address separation requirements of different compounds. The separation behaviour of two mAbs is demonstrated.
Native Online HIC–MS Analysis of mAbs
This application note shows how a mixture of seven in-house mAbs, as well as the molecular variants of two mAbs, were characterised via HIC-MS using YMC’s BioPro HIC BF column.
Native online HIC–MS of cys-linked ADCs
In this application note the DAR of the SigmaMAb ADC-mimic was determined using YMC’s BioPro HIC BF column and a nanospray ionisation mass spectrometer.
HIC Analysis of Oxidised Monoclonal Antibodies
Monoclonal antibodies and their oxidised species are separated using YMC’s more hydrophobic BioPro HIC BF column, dedicated for low hydrophobicity proteins and oxidised mAb variants.
High Resolution CEX Analysis of mAbs
Four therapeutic mAbs of different species, isotypes, and pI together with their variants were analysed using pH and salt gradient mode using YMC’s non-porous BioPro IEX SF.
Commercial MAbs by MicroLC-MS/MS
YMC-Triart Bio C4 is used in YMC capillary column format to analyse and identify intact commercial mAbs by micro LC–MS/MS at an elevated temperature of 75°C.
Native Online SCX–MS Analysis of mAbs
In this application note high-resolution SCX was coupled directly to an ultrasensitive online native MS using YMC’s BioPro IEX SF to analyse mAb charge variants.
Rapid Robust HPLC Analysis of Indoxyl Sulfate
The use of a C18 column for the analysis of indoxyl sulfate as part of a research study to measure the total levels in a simulated blood serum environment is illustrated.
On-Site Screening of Explosive Materials
Discover Coiled microextraction and SPME field collection and injection devices using portable GC–MS for separation, detection, and identification of explosive materials.
HPLC Analysis of Vitamin C Using Quasar Biphenyl Column
Vitamin C is essential for the repair of tissue and is thought to lower cancer risk. This application brief describes use of a Quasar biphenyl column in this analysis.
HPLC Analysis of Plavix Using Quasar C8 Column
Plavix tablets contain the active ingredient clopidogrel hydrogen sulphate, readily analyzed by HPLC. Use of a Quasar C8 column in the analysis of Plavix is described.