Mobile phase containing arginine provides more reliable SEC condition for aggregation analysis

Loss of protein aggregates due to matrix protein interaction during SEC often causes underestimation of aggregate content in the quality control of pharmaceutical proteins. Since new columns especially show stronger tendency to bind proteins, an effort should be made to suppress protein adsorption....

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2010-02, Vol.99 (2), p.618-620
Main Authors: Yumioka, Ryosuke, Sato, Haruna, Tomizawa, Hiroshi, Yamasaki, Yosuke, Ejima, Daisuke
Format: Article
Language:English
Subjects:
analytical biochemistry
Arginine - chemistry
Biological and medical sciences
biotechnology
Buffers
chromatography
Chromatography, Gel - methods
Chromatography, High Pressure Liquid
General pharmacology
Immunoglobulin G - chemistry
Indicators and Reagents
Medical sciences
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
protein aggregation
Sodium Chloride - chemistry
Spectrophotometry, Ultraviolet
stability
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Summary:Loss of protein aggregates due to matrix protein interaction during SEC often causes underestimation of aggregate content in the quality control of pharmaceutical proteins. Since new columns especially show stronger tendency to bind proteins, an effort should be made to suppress protein adsorption. We examined the effects of arginine on protein binding to SEC columns and found that loss of aggregates was reduced in the presence of arginine, leading to a reliable estimate of aggregate content even with newly used column and small protein load. This is not due to increased ionic strength, as NaCl resulted in increased protein loss. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:618–620, 2010
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.21857