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  • Biochemical, molecular and preclinical characterization of a double-virus-reduced human butyrylcholinesterase preparation designed for clinical use

    Author(s)
    Weber, A
    Butterweck, H
    Mais-Paul, U
    Teschner, W
    Lei, L
    Muchitsch, E-M
    Kolarich, D
    Altmann, F
    Ehrlich, HJ
    Schwarz, HP
    Griffith University Author(s)
    Kolarich, Daniel
    Year published
    2011
    Metadata
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    Abstract
    Background and Objectives:  A human plasma-derived butyrylcholinesterase preparation manufactured on the industrial scale is described. Material and Methods:  The human butyrylcholinesterase (hBChE) product was extensively investigated for its purity using immunological and electrophoretic methods and characterized by thorough glycoproteomic approaches. A comprehensive preclinical testing programme addressing safety and pharmacokinetic parameters supplemented the biochemical characterization. Results:  The high-purity hBChE preparation is tetrameric and has high specific activity and molecular integrity of the protein ...
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    Background and Objectives:  A human plasma-derived butyrylcholinesterase preparation manufactured on the industrial scale is described. Material and Methods:  The human butyrylcholinesterase (hBChE) product was extensively investigated for its purity using immunological and electrophoretic methods and characterized by thorough glycoproteomic approaches. A comprehensive preclinical testing programme addressing safety and pharmacokinetic parameters supplemented the biochemical characterization. Results:  The high-purity hBChE preparation is tetrameric and has high specific activity and molecular integrity of the protein backbone. Acute toxicity studies and in vivo thrombogenicity studies provided evidence of a sufficient safety margin for use in humans. Conclusion:  Extensive preclinical safety and pharmacokinetic testing confirmed that this hBChE preparation can be used for further efficacy testing as a bioscavenger for toxic organophosphate compounds in appropriate animal models and ultimately in humans.
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    Journal Title
    Vox Sanguinis
    Volume
    100
    Issue
    3
    DOI
    https://doi.org/10.1111/j.1423-0410.2010.01415.x
    Subject
    Clinical sciences
    Clinical sciences not elsewhere classified
    Medical physiology
    Publication URI
    http://hdl.handle.net/10072/339697
    Collection
    • Journal articles

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