Pharmaceutical Analysis Blog

Biosimilarity assessment and product quality attribute monitoring

In this application note, a Thermo Scientific™ HR-MAM workflow for biosimilarity assessment is evaluated. The study demonstrates the use of the workflow for sequence variant assessment and to monitor the variability of product quality attributes...

Applications to Improve Your Biopharmaceutical Analyses

Separation Science, in collaboration with Thermo Fisher Scientific, offers a selection of application notes relevant for biopharmaceutical analysis. Discover the latest advances in high-resolution accurate-mass (HRAM) mass spectrometry. Learn...

How to Select a Reproducible Starting Point in HPLC Method Development

Separation Science, in collaboration with Phenomenex offers an on-demand webinar 'HPLC/UHPLC Reversed-Phase Method Development: Selecting a Reproducible Starting Point' with pharma industry expert, Dr Phil Koerner.

Learn how to conduct structural analysis of impurities in pharmaceuticals

This application note will help you understand how trap-free 2D LC-MS allows online conversion of non-volatile to volatile mobile phase conditions and how the LCMS-9030’s high mass accuracy can be used to conduct structural analysis of impurities.

Sub-picogram level quantitation of desmopressin

In this study, a successful micro LC-MS/MS method for the highly sensitive quantitation of desmopressin in human plasma is demonstrated. It shows how the QTRAP® 6500+ LC MS/MS system with OptiFlow™ Source coupled with a M5 MicroLC system provides...

An improved immunoaffinity-micro LC-MS/MS workflow for quantifying trastuzumab emtansine

This study describes in detail an improved immunoaffinity-micro LC-MS/MS workflow for quantifying trastuzumab emtansine in mouse plasma using the SCIEX 6500+ QTRAP® System with OptiFlow™ Turbo V source and M5 MicroLC System.

Addressing the key challenges in the quantification of Trastuzumab

SCiEX has produced a technical note describing an immunoaffinity-high resolution accurate mass assay for the pre-clinical quantification of Trastuzumab in rat plasma.

Therapeutic peptide catabolite identification

Find, Identify and Confirm Peptide Catabolites Using MetabolitePilotTM 2.0 Software and the Advanced Biotransform Solution.

Metabolite identification of payload species of antibody drug conjugates

SCIEX has produced a technical note describing metabolite identification of payload species of antibody drug conjugates with noncleavable linkers using MetabolitePilot™ 2.0 software and TripleTOF® 6600 systems.

Get more information in less time: Improve your peptide mapping and PTM analysis skills

Peptide mapping is critical for characterizing protein drugs and monitoring product critical quality attributes (CQAs) in biopharma. Due to the heterogenous nature of protein drugs, comprehensive analytical characterization is required for...

Enabling single-software multiple attribute methodology for assessment of biopharmaceutical product quality attributes

This technical note from SCIEX will highlight how to implement a complete and easy-to-use Multiple Attribute Methodology (MAM) workflow for biotherapeutic PQA monitoring using accurate mass LC–MS. It will demonstrate how this new streamlined MAM...

Achieve high-throughput LC/MS purification of pharmaceutical impurities

Agilent Technologies has produced an application note describing the separation and purification of acetaminophen (paracetamol) and six common impurities listed in the European and United States Pharmacopoeias.

    

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