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New 2D-LC/MS approaches for the analysis of in-process samples and for the characterisation of mAbs in a regulated environment

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… Monoclonal antibodies (mAbs) represent a large part of pharmaceuticals currently … ~25 kDa connected by disulphide bridges. The production of mAbs is a lengthy and complex process. It is, however, … would be of great benefit to quickly characterise mAbs. Typical modifications followed during the production …

Characterisation of the glycosylation of Enbrel: Etanercept by high resolution mass spectrometry

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… Due to their mode of production, therapeutic glycoproteins present complex and heterogeneous glycosylations. … as a powerful tool for Etanercept glycosylation characterisation is presented. Using a comprehensive … comprehensive workflow is fully applicable to other glycoproteins, such as mAbs, ADCs, and other proteins produced by …

1D & 2D-LC/MS characterisation of mAbs for QC and stability testing

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… separation (1D and 2D-LC), data processing / reporting for mAbs isoform characterisation (batch-to-batch consistency, … peptides/amino acids). … 1D & 2D-LC/MS characterisation of mAbs for QC and stability testing … resource …

Protein aggregation

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New 2D-LC–MS Approaches for the Analysis of In-Process Samples and for the Characterisation of mAbs in a Regulated Environment

Resources

… Biologics, and in particular monoclonal antibodies (mAbs), are an important class of therapeutics, and their … validated software was used for the characterisation of mAbs in complex mixtures at the intact and subunit levels … Two approaches were developed to characterise mAbs with mass spectrometry using innovative two-dimensional …

WEBINAR: HDX-MS: a powerful tool for biopharmaceutical characterisation

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… (HDX-MS): a powerful tool for biopharmaceutical characterisation Hydrogen-Deuterium Exchange Mass … technique for the advanced structural characterisation of proteins and the study of protein-protein interactions. This technique has been used …

Mass spectrometry as a powerful tool for the characterisation of monoclonal antibodies in the context of comparability studies

Article

… spectrometry is to measure the molecular mass of the intact protein. This test can provide useful information on the identity of the protein, but also on the main glycosylation profile. Characterisation of intact antibodies The sample is first …

Oligonucleotides: A serious analytical challenge in terms of analytical characterisation

Article

… Oligonucleotides: A serious challenge in terms of analytical … by Arnaud Delobel , R&D Director at Quality Assistance S.A. Oligonucleotides are a promising class of therapeutics that … we solely focus on the analytical characterisation of oligonucleotides and on the development and validation of …

A new alternative tool to analyse glycosylation in pharmaceutical proteins based on infrared spectroscopy combined with nonlinear support vector regression

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… Abstract Almost 60% of commercialized pharmaceutical proteins are glycosylated. Glycosylation is considered a … as it affects the stability, bioactivity and safety of proteins. Hence, the development of analytical methods to characterise the composition and structure of glycoproteins is crucial. Currently, existing methods are …

Characterisation of anti-HCP antibodies by 2D-Differential Gel Electrophoresis (2D-DIGE)

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… Host-cell proteins are a major class of process-related impurities in … . This webcast describes an alternative approach for the characterisation of the HCP coverage of these anti-HCP … be used for routine testing of residual HCPs in therapeutic proteins is appropriate. Compared to traditional Western …