Application Notes: LC

IgdE allows for better characterization of the antibody and yields an intact Fc and an intact Fab fragment that can be further isolated and characterized.

Comparing core-shell superficially porous to fully porous particles to determine efficiency required for detection, separation of low-level impurities for subunit analysis.

A reversed-phase method using a superficially porous, wide pore particle morphology for the quantitation of coformulated mAbs leads to high efficiency separations.

For LC–MS analysis of NIST mAb, multiple C4 LC columns are compared to determine which provides necessary separation of impurity and avoids spectral overlap in the MS detector.

The performance of basic pharmaceuticals is compared to the charged surface Agilent InfinityLab Poroshell 120 CS-C18 and a C18 with formic acid mobile phase.

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.

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.

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.

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”.

Analyzing diverse method parameters, such as temperature, gradient program, and flow rates for optimization of intact mass applications when using bioZen WidePore C4.

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.

The unique selectivity of four Agilent InfinityLab Poroshell 120 C18 columns is shown with veterinary drugs using a simple formic acid and acetonitrile gradient.

Using Empower CDS and NuGenesis LMS to develop an archive strategy that reduces backup and recovery times and removes manual intervention is demonstrated.

Companies can seek outside help for backup and restore, disaster recovery, and system administration, but responsibility for regulated data remains with the company.

VITAQUEST, a contract manufacturer of dietary supplements, used NuGenesis LMS to automate its workflows, improve lab efficiency, and reduce the risk for data errors.

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.

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.

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.

A&M Stabtest, an independent CRO in the pharmaceutical industry, reduced time-consuming and error-prone manual steps in the chromatographic testing process.

An investment in Waters NuGenesis LMS helped a global pharmaceutical CDMO meet demands for data integrity regulatory compliance and laboratory management needs.

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.

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.

Accurate detection of HAA’s is paramount for the prevention of over oxidation, while still managing enough water sanitation to eliminate water borne pathogens.

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.

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.

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.

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.

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.

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.

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.