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

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Year: 2008
Type: article
Source: Journal of Pharmaceutical Sciences
DOI: 10.1002/jps.21530
Authors: John F. Carpenter, Theodore W. Randolph, Wim Jiskoot, Daan J.A. Crommelin, C. Russell Middaugh, Gerhard Winter, Ying-Xin Fan, Susan Kirshner, Daniela Verthelyi, Steven Kozlowski, Kathleen A. Clouse, Patrick G. Swann, Amy Rosenberg, Barry Cherney
Institutions: University of Colorado Health, University of Colorado Denver, University of Colorado Boulder, Leiden University, Utrecht University, University of Kansas, Ludwig-Maximilians-Universität München, United States Food and Drug Administration, Center for Drug Evaluation and Research
Language: English

Topic: Protein purification and stability
Subfield: Molecular Biology
Field: Biochemistry, Genetics and Molecular Biology
Domain: Life Sciences
SDG: Good health and well-being

Open Access status: green

Funder: National Institute of Biomedical Imaging and Bioengineering
Award: Biotechnology Research Partnerships Renewal: Aggregation of Therapeutic Proteins
OpenAlex ID: W2138317859
FWCI: 8.01
Cites: 18
Cited by: 608
Related to: 10
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