Strategies for the Assessment of Protein Aggregates in Pharmaceutical Biotech Product Development

被引：285

作者：

den Engelsman, John ^{[2
]}

Garidel, Patrick ^{[3
]}

Smulders, Ronald ^{[2
]}

Koll, Hans ^{[4
]}

Smith, Bryan ^{[5
]}

Bassarab, Stefan ^{[3
]}

Seidl, Andreas ^{[6
]}

Hainzl, Otmar ^{[6
]}

Jiskoot, Wim ^{[1
]}

机构：

[1] Leiden Univ, Div Drug Delivery Technol, Leiden Amsterdam Ctr Drug Res, NL-2300 RA Leiden, Netherlands

[2] MSD, Oss, Netherlands

[3] Boehringer Ingelheim Pharma GmbH & Co KG, Dept Proc Sci Biopharmaceut, Biberach, Germany

[4] Roche Pharma Res & Early Dev, Biol Res Prot Analyt, Penzberg, Germany

[5] UCB, Slough, Berks, England

[6] Hexal AG, Sandoz Biopharmaceut, Analyt Characterizat, Oberhaching, Germany

来源：

PHARMACEUTICAL RESEARCH | 2011年 / 28卷 / 04期

关键词：

aggregation; aggregates; analytical characterization; biotech products; commentary; drug development; particles; proteins; recommendation; SIZE-EXCLUSION CHROMATOGRAPHY; VELOCITY ANALYTICAL ULTRACENTRIFUGATION; FIELD-FLOW FRACTIONATION; HETEROGENEOUS NUCLEATION; MONOCLONAL-ANTIBODY; MOBILE-PHASE; SILICONE OIL; QUANTITATION; STABILITY; PRECISION;

D O I：

10.1007/s11095-010-0297-1

中图分类号：

O6 [化学];

学科分类号：

0703 ;

摘要：

Within the European Immunogenicity Platform (EIP) (http://www.e-i-p.eu), the Protein Characterization Subcommittee (EIP-PCS) has been established to discuss and exchange experience of protein characterization in relation to unwanted immunogenicity. In this commentary, we, as representatives of EIP-PCS, review the current state of methods for analysis of protein aggregates. Moreover, we elaborate on why these methods should be used during product development and make recommendations to the biotech community with regard to strategies for their application during the development of protein therapeutics.

引用

页码：920 / 933

页数：14

共 34 条

[1]

[Anonymous], 2010, PHARMEUROPA, V22, P49

[2] The Critical Role of Mobile Phase Composition in Size Exclusion Chromatography of Protein Pharmaceuticals [J].

Arakawa, Tsutomu ;

Ejima, Daisuke ;

Li, Tiansheng ;

Phil, John S. .

JOURNAL OF PHARMACEUTICAL SCIENCES, 2010, 99 (04) :1674-1692

[3] 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

[4]

Berne BJ, 2000, DYNAMIC LIGHT SCATTE

[5] Protein stability during freezing: Separation of stresses and mechanisms of protein stabilization [J].

Bhatnagar, Bakul S. ;

Bogner, Robin H. ;

Pikal, Michael J. .

PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, 2007, 12 (05) :505-523

[6] 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 [J].

Carpenter, John F. ;

Randolph, Theodore W. ;

Jiskoot, Wim ;

Crommelin, Daan J. A. ;

Middaugh, C. Russell ;

Winter, Gerhard .

JOURNAL OF PHARMACEUTICAL SCIENCES, 2010, 99 (05) :2200-2208

[7] Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality [J].

Carpenter, John F. ;

Randolph, Theodore W. ;

Jiskoot, Wim ;

Crommelin, Daan J. A. ;

Middaugh, C. Russell ;

Winter, Gerhard ;

Fan, Ying-Xin ;

Kirshner, Susan ;

Verthelyi, Daniela ;

Kozlowski, Steven ;

Clouse, Kathleen A. ;

Swann, Patrick G. ;

Rosenberg, Amy ;

Cherney, Barry .

JOURNAL OF PHARMACEUTICAL SCIENCES, 2009, 98 (04) :1201-1205

[8] Heterogeneous nucleation-controlled particulate formation of recombinant human platelet-activating factor acetylhydrolase in pharmaceutical formulation [J].

Chi, EY ;

Weickmann, J ;

Carpenter, JF ;

Manning, MC ;

Randolph, TW .

JOURNAL OF PHARMACEUTICAL SCIENCES, 2005, 94 (02) :256-274

[9] Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation [J].

Chi, EY ;

Krishnan, S ;

Randolph, TW ;

Carpenter, JF .

PHARMACEUTICAL RESEARCH, 2003, 20 (09) :1325-1336

[10] Protein aggregation mediated by cysteine oxidation during the stacking phase of discontinuous buffer SDS-PAGE [J].

Crow, MK ;

Karasavvas, N ;

Sarris, AH .

BIOTECHNIQUES, 2001, 30 (02) :311-316

← 1 2 3 4 →