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OnabotulinumtoxinA Displays Greater Biological Activity Compared to IncobotulinumtoxinA, Demonstrating Non-Interchangeability in Both In Vitro and In Vivo Assays

1
Allergan, an AbbVie company, Irvine, CA 92612, USA
2
Faculty of Health, University Witten/Herdecke, 58455 Witten, Germany
3
Department of Neurology, University of California, Irvine, Irvine, CA 92697, USA
*
Author to whom correspondence should be addressed.
Toxins 2020, 12(6), 393; https://doi.org/10.3390/toxins12060393
Received: 13 May 2020 / Revised: 8 June 2020 / Accepted: 10 June 2020 / Published: 13 June 2020
(This article belongs to the Section Bacterial Toxins)
Differences in botulinum neurotoxin manufacturing, formulation, and potency evaluation can impact dose and biological activity, which ultimately affect duration of action. The potency of different labeled vials of incobotulinumtoxinA (Xeomin®; 50 U, 100 U, or 200 U vials; incobotA) versus onabotulinumtoxinA (BOTOX®; 100 U vial; onabotA) were compared on a unit-to-unit basis to assess biological activity using in vitro (light-chain activity high-performance liquid chromatography (LCA-HPLC) and cell-based potency assay (CBPA)) and in vivo (rat compound muscle action potential (CMAP) and mouse digit abduction score (DAS)) assays. Using LCA-HPLC, incobotA units displayed approximately 54% of the protease activity of label-stated equivalent onabotA units. Lower potency, reflected by higher EC50, ID50, and ED50 values (pooled mean ± SEM), was displayed by incobotA compared to onabotA in the CBPA (EC50: incobotA 7.6 ± 0.7 U/mL; onabotA 5.9 ± 0.5 U/mL), CMAP (ID50: incobotA 0.078 ± 0.005 U/rat; onabotA 0.053 ± 0.004 U/rat), and DAS (ED50: incobotA 14.2 ± 0.5 U/kg; onabotA 8.7 ± 0.3 U/kg) assays. Lastly, in the DAS assay, onabotA had a longer duration of action compared to incobotA when dosed at label-stated equivalent units. In summary, onabotA consistently displayed greater biological activity than incobotA in two in vitro and two in vivo assays. Differences in the assay results do not support dose interchangeability between the two products. View Full-Text
Keywords: BOTOX; cell-based potency assay (CBPA); compound muscle action potential (CMAP) electrophysiology assay; digit abduction score (DAS) assay; dose conversion; interchangeability; light-chain activity high-performance liquid chromatograph (LCA-HPLC) assay; potency; Xeomin BOTOX; cell-based potency assay (CBPA); compound muscle action potential (CMAP) electrophysiology assay; digit abduction score (DAS) assay; dose conversion; interchangeability; light-chain activity high-performance liquid chromatograph (LCA-HPLC) assay; potency; Xeomin
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Rupp, D.; Nicholson, G.; Canty, D.; Wang, J.; Rhéaume, C.; Le, L.; Steward, L.E.; Washburn, M.; Jacky, B.P.; Broide, R.S.; Philipp-Dormston, W.G.; Brin, M.F.; Brideau-Andersen, A. OnabotulinumtoxinA Displays Greater Biological Activity Compared to IncobotulinumtoxinA, Demonstrating Non-Interchangeability in Both In Vitro and In Vivo Assays. Toxins 2020, 12, 393.

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