Title: Biochemical, functional and potency characteristics of type A botulinum toxin in clinical use

Authors: Naveed Panjwani, Roderic O'Keeffe, Andy Pickett

Addresses: Industrialisation Group, Ipsen Biopharm Limited, Ash Road North, Wrexham LL13 9UF, UK. ' Pharmaceutical Development, Ipsen Biopharm Limited, Ash Road North, Wrexham LL13 9UF, UK. ' Biologicals Science and Technology, Ipsen Biopharm Limited, Ash Road North, Wrexham LL13 9UF, UK

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]

Keywords: botulinum neurotoxins; BoNT; specific potency; protein load; biochemical characteristics; functional characteristics; botulinum type A toxin; botulism; toxin–haemagglutinin complex; haemagglutinin; batch-to-batch consistency.

DOI: 10.1504/TBJ.2008.018956

The Botulinum Journal, 2008 Vol.1 No.1, pp.153 - 166

Published online: 25 Jun 2008 *

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