Mass Spectrometry In-Depth Focus 2018
Posted: 1 March 2018 | European Pharmaceutical Review | No comments yet
This In-Depth Focus looks at the benefits of mass spectrometry for the characterisation of protein higher order structure and for stability testing.
- Characterisation of higher order structure of protein pharmaceuticals with mass spectrometry
Mass spectrometry is used extensively to determine protein structure and modification. Benefits for the characterisation of protein higher order structure include comprehensive collection of structural data, speed of analyses, reduced sample consumption, and good resolution.
- Stability testing
Stability testing provides evidence on how the quality of drug substance or product varies with time under the influence of different environmental factors, eg, temperature, humidity, light, and allows the establishment of a re-test period (or shelf-life) for the drug substance or product. This will always involve an understanding of the underlying degradation pathways, ie, hydrolysis, oxidation, photolysis, etc, and that understanding will evolve as the drug substance and product progresses towards commercialisation and NDA/MAA applications.
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Analytical techniques, Mass Spectrometry, New Drug Application (NDA), protein structure