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

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Weber, A
Butterweck, H
Mais-Paul, U
Teschner, W
Lei, L
Muchitsch, E-M
Kolarich, D
Altmann, F
Ehrlich, HJ
Schwarz, HP
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2011
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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 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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Vox Sanguinis

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100

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3

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Clinical sciences

Clinical sciences not elsewhere classified

Medical physiology

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