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Overlooking Subvisible Particles in Therapeutic Protein Products

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

JOHN F. CARPENTER,1 THEODORE W. RANDOLPH,2 WIM JISKOOT,3 DAAN J.A. CROMMELIN,4 C. RUSSELL MIDDAUGH,5 GERHARD WINTER,6 YING-XIN FAN,7 SUSAN KIRSHNER,7 DANIELA VERTHELYI,7 STEVEN KOZLOWSKI,8 KATHLEEN A. CLOUSE,9 PATRICK G. SWANN,9 AMY ROSENBERG,7 BARRY CHERNEY7

1Department of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, Box 238, University of Colorado Health Sciences Center, Denver, Colorado 80262

2Department of Chemical and Biological Engineering, Center for Pharmaceutical Biotechnology, University of Colorado, Boulder, Colorado 80309

3Division of Drug Delivery Technology, Leiden/Amsterdam Center for Drug Research (LACDR), Leiden University, Leiden, The Netherlands

4Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands

5Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, Kansas 66047

6Department of Pharmacy, Ludwig Maximilians University, 81377 Munich, Germany

7Division of Therapeutic Proteins, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857

8Office of Biotechnology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857

9Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857

PUBLICATION: Journal of Pharmaceutical Sciences. 98(4): 1201-1205. (2009)
DOI 10.1002/jps.21530

LINK TO ARTICLE: http://onlinelibrary.wiley.com/doi/10.1002/jps.21530/abstrac

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