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Particles in therapeutic protein formulations, Part 1: Overview of analytical methods

Authors

  • Sarah Zölls,

    1. Coriolis Pharma, Am Klopferspitz 19, 82152 Martinsried-Munich, Germany
    2. Department of Pharmacy and Biopharmaceutics, Pharmaceutical Technology, Ludwig Maximilian University, 81377 Munich, Germany
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  • Ruedeeporn Tantipolphan,

    1. Coriolis Pharma, Am Klopferspitz 19, 82152 Martinsried-Munich, Germany
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  • Michael Wiggenhorn,

    1. Coriolis Pharma, Am Klopferspitz 19, 82152 Martinsried-Munich, Germany
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  • Gerhard Winter,

    1. Department of Pharmacy and Biopharmaceutics, Pharmaceutical Technology, Ludwig Maximilian University, 81377 Munich, Germany
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  • Wim Jiskoot,

    1. Division of Drug Delivery Technology, Leiden/Amsterdam Center for Drug Research, Leiden University, 2300 RA Leiden, The Netherlands
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  • Wolfgang Friess,

    1. Department of Pharmacy and Biopharmaceutics, Pharmaceutical Technology, Ludwig Maximilian University, 81377 Munich, Germany
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  • Andrea Hawe

    Corresponding author
    1. Coriolis Pharma, Am Klopferspitz 19, 82152 Martinsried-Munich, Germany
    2. Division of Drug Delivery Technology, Leiden/Amsterdam Center for Drug Research, Leiden University, 2300 RA Leiden, The Netherlands
    • Coriolis Pharma, Am Klopferspitz 19, 82152 Martinsried-Munich, Germany. E-mail: andrea.hawe@coriolis-pharma.com Phone: +49-89-5424498-25, Fax: +49-89-5424498-22
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Abstract

The presence of particles is a major issue during therapeutic protein formulation development. Both proteinaceous and nonproteinaceous particles need to be analyzed not only due to the requirements of the Pharmacopeias but also to monitor the stability of the protein formulation. Increasing concerns about the immunogenic potential together with new developments in particle analysis make a comparative description of established and novel analytical methods useful. Our review aims to provide a comprehensive overview on analytical methods for the detection and characterization of visible and subvisible particles in therapeutic protein formulations. We describe the underlying theory, benefits, shortcomings, and illustrative examples for quantification techniques, as well as characterization techniques for particle shape, morphology, structure, and identity. © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 101:914–935, 2012

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