Biopharmaceutical quality control with mass spectrometry
Shulei Liu1,2, Benjamin L Schulz1,2
1School of Chemistry & Molecular Biosciences, The University of Queensland, St Lucia, QLD 4072, Australia.
Bioanalysis
|August 31, 2021
Summary
Mass spectrometry (MS) is vital for analyzing biopharmaceuticals, offering insights into protein quantity, structure, and modifications. Recent advancements enhance its application in biopharmaceutical quality control and manufacturing.
Area of Science:
- Biochemistry
- Analytical Chemistry
- Biopharmaceutical Science
Background:
- Mass spectrometry (MS) is a crucial technique in biochemical studies for protein analysis.
- It provides data on protein quantity, structural integrity, and post-translational modifications.
- MS is extensively used for quality control in biopharmaceutical development and manufacturing.
Purpose of the Study:
- To summarize recent advancements in mass spectrometry-based analyses for biopharmaceuticals.
- To highlight the application of MS in assessing key quality attributes during biopharmaceutical development and manufacturing.
Main Methods:
- Review of recent literature on mass spectrometry techniques.
- Focus on MS applications in protein identification, quantification, and characterization.
- Emphasis on MS for analyzing host-cell protein impurities, post-translational modifications, and structural integrity.
Main Results:
- Recent MS advances improve the analysis of biopharmaceutical quality attributes.
- Enhanced capabilities in quantifying host-cell protein impurities.
- Improved identification of post-translational modifications and structural characterization.
Conclusions:
- Mass spectrometry is an indispensable tool for biopharmaceutical quality control.
- Continued advancements in MS are critical for robust biopharmaceutical development and manufacturing.
- MS enables comprehensive characterization of biopharmaceutical proteins.
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