Cited by 196Protein purification and stabilityBiosimilars and Bioanalytical MethodsAnalytical Methods in Pharmaceuticals

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A Critical Review of Methods for Size Characterization of Non-Particulate Protein Aggregates

Philo, John·2009·Current Pharmaceutical Biotechnology

DOI 10.2174/138920109788488815

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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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Techniques in Protein Chemistry
(1993) · Journal of the American Society for Mass Spectrometry · doi:10.1016/1044-0305(93)80012-n · Cited by 1,298

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Authors: Philo, J.
Affiliations: Alliance Protein Laboratories (United States) (US)
Corresponding author: Philo, John
ORCID: Philo, John
Venue: Current Pharmaceutical Biotechnology
Publisher: Bentham Science Publishers Ltd.
Published: 2009-06-01
Volume: 10
Issue: 4
Pages: 359-372
ISSN: 1389-2010 (ISSN-L)
DOI: 10.2174/138920109788488815
OpenAlex: W2007228224
Cited by: 196
References: 1
Citations by year: 2025: 4 · 2024: 6 · 2023: 7 · 2022: 8 · 2021: 7 · 2020: 8 · 2019: 14 · 2018: 12 · 2017: 11 · 2016: 13 · 2015: 22 · 2014: 19 · 2013: 13 · 2012: 24
FWCI: 6.97
Type: journal article
Language: en
Open access: closed
Locations: Current Pharmaceutical Biotechnology (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
Keywords: protein aggregates, size exclusion chromatography, analytical ultracentrifugation, light scattering, pharmaceutical proteins, regulatory compliance, biophysical characterization
MeSH terms: Biopharmaceutics, Chromatography, Gel, Chemical Fractionation, Nephelometry and Turbidimetry, Particle Size, Proteins, Technology, Pharmaceutical, Ultracentrifugation, Multiprotein Complexes

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A Critical Review of Methods for Size Characterization of Non-Particulate Protein Aggregates

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