Stability of botulinum neurotoxin type A, devoid of complexing proteins
by Swen Grein, Gerd J. Mander, Klaus Fink
The Botulinum J. (TBJ), Vol. 2, No. 1, 2011

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.

Online publication date: Sat, 06-Aug-2011

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