Overlooking subvisible particles in therapeutic protein products: Gaps that may compromise product quality

Authors

  • John F. Carpenter,

    Corresponding author
    1. Department of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, Box 238, University of Colorado Health Sciences Center, Denver, Colorado 80262
    • Department of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, Box 238, University of Colorado Health Sciences Center, Denver, Colorado 80262. Telephone: 303-315-6075; Fax: 303-315-6281.
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  • Theodore W. Randolph,

    1. Department of Chemical and Biological Engineering, Center for Pharmaceutical Biotechnology, University of Colorado, Boulder, Colorado 80309
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  • Wim Jiskoot,

    1. Division of Drug Delivery Technology, Leiden/Amsterdam Center for Drug Research (LACDR), Leiden University, Leiden, The Netherlands
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  • Daan J.A. Crommelin,

    1. Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands
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  • C. Russell Middaugh,

    1. Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, Kansas 66047
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  • Gerhard Winter,

    1. Department of Pharmacy, Ludwig Maximilians University, 81377 Munich, Germany
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  • Ying-Xin Fan,

    1. Division of Therapeutic Proteins, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857
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  • Susan Kirshner,

    1. Division of Therapeutic Proteins, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857
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  • Daniela Verthelyi,

    1. Division of Therapeutic Proteins, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857
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  • Steven Kozlowski,

    1. Office of Biotechnology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857
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  • Kathleen A. Clouse,

    1. Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857
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  • Patrick G. Swann,

    1. Division of Monoclonal Antibodies, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857
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  • Amy Rosenberg,

    1. Division of Therapeutic Proteins, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857
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  • Barry Cherney

    1. Division of Therapeutic Proteins, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857
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  • The information here reflects the current thinking and scientific judgment of the authors. However, this is not a policy document and should not be used in lieu of regulations, published guidance, or direct discussions with regulators.

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