Abstract
Although size exclusion chromatography (SEC) has been, and will continue to be, the primary analytical tool for characterization of the content and size distribution of non-particulate aggregates in protein pharmaceuticals, regulatory concerns are driving increased use of alternative and complementary methods such as analytical ultracentrifugation and light scattering techniques. This review will highlight and critically review the capabilities, advantages, and drawbacks of SEC, analytical ultracentrifugation, and light scattering methods for characterizing aggregates with sizes below about 0.3 microns. The physical principles of the biophysical methods are briefly described and examples of data for real samples and how that data is interpreted are given to help clarify capabilities and weaknesses.
Keywords: Aggregate, analytical ultracentrifugation, light scattering, sedimentation velocity, size exclusion chromatography, oligomer
Current Pharmaceutical Biotechnology
Title: A Critical Review of Methods for Size Characterization of Non-Particulate Protein Aggregates
Volume: 10 Issue: 4
Author(s): John S. Philo
Affiliation:
Keywords: Aggregate, analytical ultracentrifugation, light scattering, sedimentation velocity, size exclusion chromatography, oligomer
Abstract: Although size exclusion chromatography (SEC) has been, and will continue to be, the primary analytical tool for characterization of the content and size distribution of non-particulate aggregates in protein pharmaceuticals, regulatory concerns are driving increased use of alternative and complementary methods such as analytical ultracentrifugation and light scattering techniques. This review will highlight and critically review the capabilities, advantages, and drawbacks of SEC, analytical ultracentrifugation, and light scattering methods for characterizing aggregates with sizes below about 0.3 microns. The physical principles of the biophysical methods are briefly described and examples of data for real samples and how that data is interpreted are given to help clarify capabilities and weaknesses.
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Cite this article as:
Philo S. John, A Critical Review of Methods for Size Characterization of Non-Particulate Protein Aggregates, Current Pharmaceutical Biotechnology 2009; 10 (4) . https://dx.doi.org/10.2174/138920109788488815
DOI https://dx.doi.org/10.2174/138920109788488815 |
Print ISSN 1389-2010 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4316 |
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