Title: Stability of botulinum neurotoxin type A, devoid of complexing proteins

Authors: Swen Grein, Gerd J. Mander, Klaus Fink

Addresses: Merz Pharmaceuticals GmbH, Department Biotechnology, Eckenheimer Landstr 100, 60318 Frankfurt, Germany. ' Merz Pharmaceuticals GmbH, Department Biotechnology, Eckenheimer Landstr 100, 60318 Frankfurt, Germany. ' Merz Pharmaceuticals GmbH, Department Biotechnology, Eckenheimer Landstr 100, 60318 Frankfurt, Germany

Abstract: Botulinum toxin type A is a complex composed of the biologically active neurotoxin, several hemagglutinins and other nontoxic proteins. After intramuscular injection these complexing proteins do not have any therapeutic effect. However, they protect the neurotoxin from harsh environmental conditions, e.g., low intragastral pH after oral ingestion. NT201, a BoNT/A drug product devoid of complexing proteins was tested in real-time and accelerated stability studies. NT201 was found to be stable without refrigeration for 48 months and even not affected by short-term temperature stress up to 60°C, demonstrating that complexing proteins are not required for the stability of BoNT/A preparations.

Keywords: botulinum neurotoxin type A; BoNT/A; stability; complexing proteins; temperature stress; ICH guideline; botulinum neurotoxins.

DOI: 10.1504/TBJ.2011.041815

The Botulinum Journal, 2011 Vol.2 No.1, pp.49 - 58

Published online: 06 Aug 2011 *

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