Biochemical, functional and potency characteristics of type A botulinum toxin in clinical use. (26th June 2008)

• Record Type: Journal Article
• Authors: Panjwani, Naveed; O'Keeffe, Roderic; Pickett, Andy
• Is Part Of: Botulinum journal. Volume 1:Number 1(2008)
• Page Start: 153
• Page End: 166
• Publication Date: 2008-06-26
• Subjects: botulinum neurotoxins -- BoNT -- specific potency -- protein load -- biochemical characteristics -- functional characteristics -- botulinum type A toxin -- botulism -- toxin?haemagglutinin complex -- haemagglutinin -- batch-to-batch consistency; Botulinum toxin -- Periodicals; Clostridium botulinum -- Periodicals; Drug development -- Periodicals; 615.9529364
• Languages: English
• ISSNs: 1754-7318

Abstract

Dysport? (botulinum type A toxin; BoNT-A) 500 LD50 unit vial was first licensed for clinical use in 1990. Inter-batch reproducibility and comparability of the Dysport toxin?haemagglutinin complex must ensure the consistency of clinical material. The specific potency (potency per unit weight of toxin protein) provides the level of protein administered per injection. We report a high degree of batch-to-batch consistency for the long-term specific potency of Dysport, with a mean toxin protein content of 4.35 ng per 500 LD50 unit vial, based upon consistent bulk toxin data. Additional biochemical and functional data demonstrate the consistency and reliability of Dysport. [Received 4 November 2007; Accepted 12 December 2007]