Pharmaceutical Analysis

Methods and applications in biopharmaceutical characterization eBook

Are you looking for solutions to your biopharmaceutical workflows? Struggling with your intact protein analysis, or need help with glycosylation studies? If so Separation Science, in collaboration with Thermo Fisher Scientific, has developed an eBook focused on analytical solutions for biopharmaceutical characterization.

This learning resource has been divided by discipline and comprises methods, applications and case studies covering key issues relating to intact protein analysis, labeled and unlabeled glycan analysis, aggregate analysis and charge variants. Topics covered include...

Intact Protein Analysis
The complexity of modern therapeutic proteins presents a significant analytical challenge requiring high-resolution chromatography combined with high-resolution mass spectrometry. Intact protein analysis under native mass spectrometric conditions can now be performed routinely.

Monoclonal Subunit Mass Analysis
Middle-up techniques for fast, efficient separation using reversed-phase chromatography for the characterization of mAb variants.

Peptide Mapping Analysis
Peptide mapping is a critical step during biotherapeutic characterization. The so-called “bottom up” characterization of biologic drugs by protein digestion to their constituent peptides is necessary to ensure a full sequence coverage of the biopharmaceutical molecule.

Labeled Glycan Analysis
Released glycans have no chromophore and a poor response with conventional UV detection. They can be labeled with fluorescent and/or mass spectrometric tags prior to high sensitivity analysis by fluorescence detection.

Unlabeled Glycan Analysis
Glycans are often derivitized prior to analysis, but it is also possible to analyse both N-glycans and O-glycans in a label-free form, typically using ion chromatography (IC) or liquid chromatography with charged aerosol detection. As an alternative, liquid chromatography with the correct choice of detector can also be used.

Aggregate Analysis
Monitoring protein aggregates is important for safety and quality assurance. Investigators routinely use size-exclusion chromatography (SEC), which separates particles according to hydrodynamic size. Recently the use of hydrophobic interaction chromatography (HIC) has also received great interest as an orthogonal technique to SEC.

Charge Variant Analysis
The presence of the charged state can significantly impact the structure, stability, binding affinity, and efficacy of the biotherapeutic drug. It is therefore necessary to understand the profile of the drug so that charge variants are identified and removed if necessary. The heterogeneity of monoclonal antibodies is revealed by charge sensitive methods, such as ion exchange chromatography (IEX).

To download your free copy visit the biopharmaceutical resource center by clicking the button below...

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