Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality

被引：433

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
]}

Fan, Ying-Xin ^{[7
]}

Kirshner, Susan ^{[7
]}

Verthelyi, Daniela ^{[7
]}

Kozlowski, Steven ^{[8
]}

Clouse, Kathleen A. ^{[9
]}

Swann, Patrick G. ^{[9
]}

Rosenberg, Amy ^{[7
]}

Cherney, Barry ^{[7
]}

机构：

[1] Univ Colorado, Hlth Sci Ctr, Dept Pharmaceut Sci, Ctr Pharmaceut Biotechnol, Denver, CO 80262 USA

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

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

[7] US FDA, Div Therapeut Prot, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA

[8] US FDA, Off Biotechnol Prod, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA

[9] US FDA, Div Monoclonal Antibodies, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA

来源：

JOURNAL OF PHARMACEUTICAL SCIENCES | 2009年 / 98卷 / 04期

关键词：

IMMUNOGENICITY; STABILITY;

D O I：

10.1002/jps.21530

中图分类号：

R914 [药物化学];

学科分类号：

100701 ;

摘要：

[No abstract available]

引用

页码：1201 / 1205

页数：5

共 16 条

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