| Title : Biochemical, molecular and preclinical characterization of a double-virus-reduced human butyrylcholinesterase preparation designed for clinical use - Weber_2011_Vox.Sang_100_285 |
| Author(s) : Weber A , Butterweck H , Mais-Paul U , Teschner W , Lei L , Muchitsch EM , Kolarich D , Altmann F , Ehrlich HJ , Schwarz HP |
| Ref : Vox Sang , 100 :285 , 2011 |
|
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. |
| PubMedSearch : Weber_2011_Vox.Sang_100_285 |
| PubMedID: 20946535 |
Weber A, Butterweck H, Mais-Paul U, Teschner W, Lei L, Muchitsch EM, Kolarich D, Altmann F, Ehrlich HJ, Schwarz HP (2011)
Biochemical, molecular and preclinical characterization of a double-virus-reduced human butyrylcholinesterase preparation designed for clinical use
Vox Sang
100 :285
Weber A, Butterweck H, Mais-Paul U, Teschner W, Lei L, Muchitsch EM, Kolarich D, Altmann F, Ehrlich HJ, Schwarz HP (2011)
Vox Sang
100 :285