Potential Inaccurate Quantitation and Sizing of Protein Aggregates by Size Exclusion Chromatography: Essential Need to Use Orthogonal Methods to Assure the Quality of Therapeutic Protein Products

被引：144

作者：

Carpenter, John F. ^{[1
]}

Randolph, Theodore W. ^{[2
]}

Jiskoot, Wim ^{[3
]}

Crommelin, Daan J. A. ^{[4
]}

Middaugh, C. Russell ^{[5
]}

Winter, Gerhard ^{[6
]}

机构：

[1] Univ Colorado Denver, Ctr Pharmaceut Biotechnol, Dept Pharmaceut Sci, Aurora, CO 80045 USA

[2] Univ Colorado, Ctr Pharmaceut Biotechnol, Dept Chem & Biol Engn, Boulder, CO 80309 USA

[3] Leiden Univ, LACDR, Div Drug Delivery Technol, Leiden, Netherlands

[4] Univ Utrecht, Utrecht Inst Pharmaceut Sci, Dept Pharmaceut, Utrecht, Netherlands

[5] Univ Kansas, Dept Pharmaceut Chem, Lawrence, KS 66047 USA

[6] Univ Munich, Dept Pharm, D-81377 Munich, Germany

来源：

JOURNAL OF PHARMACEUTICAL SCIENCES | 2010年 / 99卷 / 05期

关键词：

biophysical models; protein aggregation; protein formulation; high-performance/pressure liquid chromatography (HPLC); analytical ultracentrifugation; analytical biochemistry; physical stability; FIELD-FLOW FRACTIONATION; VELOCITY ANALYTICAL ULTRACENTRIFUGATION; ANTIBODY; IMMUNOGENICITY; SEPARATION;

D O I：

10.1002/jps.21989

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

引用

页码：2200 / 2208

页数：9

共 45 条

[1] Detection of aggregate formation during production of human immunoglobulin G by means of light scattering [J].

Ahrer, K ;

Buchacher, A ;

Iberer, G ;

Jungbauer, A .

JOURNAL OF CHROMATOGRAPHY A, 2004, 1043 (01) :41-46

[2] Analysis of aggregates of human immunoglobulin G using size-exclusion chromatography, static and dynamic light scattering [J].

Ahrer, K ;

Buchacher, A ;

Iberer, G ;

Josic, D ;

Jungbauer, A .

JOURNAL OF CHROMATOGRAPHY A, 2003, 1009 (1-2) :89-96

[3]

ARAKAWA T, 2009, J PHARM SCI IN PRESS

[4] Detection of Protein Aggregates by Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC): Sources of Variability and Their Relative Importance [J].

Arthur, Kelly K. ;

Gabrielson, John P. ;

Kendrick, Brent S. ;

Stoner, Michael R. .

JOURNAL OF PHARMACEUTICAL SCIENCES, 2009, 98 (10) :3522-3539

[5]

BAI S, UNPUB

[6] Role of analytical ultracentrifugation in assessing the aggregation of protein biopharmaceuticals [J].

Berkowitz, Steven A. .

AAPS JOURNAL, 2006, 8 (03) :E590-E605

[7] A Bayesian Approach for Quantifying Trace Amounts of Antibody Aggregates by Sedimentation Velocity Analytical Ultracentrifugation [J].

Brown, Patrick H. ;

Balbo, Andrea ;

Schuck, Peter .

AAPS JOURNAL, 2008, 10 (03) :481-493

[8] Separation and Characterization of Protein Aggregates and Particles by Field Flow Fractionation [J].

Cao, Shawn ;

Pollastrini, Joey ;

Jiang, Yijia .

CURRENT PHARMACEUTICAL BIOTECHNOLOGY, 2009, 10 (04) :382-390

[9]

CARPENTER JP, UNPUB

[10]

CHERNEY B, 2009, COMMUNICATION

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