Objectives: To quantify the amount of botulinum toxin-A (BoNT-A) protein in each vial of commercial BoNT-A product and compare the light chain activity of 150 kDa BoNT-A in different products.
Introduction: BoNT-A effects are mediated by the 150 kDa BoNT-A neurotoxin. Each product available has a unique manufacturing process, different excipients and noninterchangeable potency units. For example, in glabellar lines, total doses are abobotulinumtoxinA (AboBoNT-A) 50U, onabotulinumtoxinA (OnaBoNT-A) 20U, and incobotulinumtoxinA (IncoBoNT-A) 20U. Light chain activity of 150 kDa BoNT-A in different products is unknown.
Materials / method: We used sandwich ELISA with antibodies specific to 150 kDa BoNT-A to quantify the amount (pg) of 150 kDa BoNT-A in each product; each of the commercial products were quantitated versus a calibration curve of recombinant, pure BoNT-A. Light chain activity was assessed using EndoPep assay, where the concentration of the cleaved target was measured and quantity of 150 kDa BoNT-A determined relative to quantity of recombinant BoNT-A required for equivalent light chain activity.
Results: The amount of neurotoxin per product unit was: AboBoNT-A (5.38pg), OnaBoNT-A (9.04pg) and IncoBoNT-A (4.03pg). There were no significant differences between BoNT products in light-chain activity. Thus, when total recommended doses for glabellar lines are injected, there is more neurotoxin injected in AboBoNT-A (50U x 5.38pg = 0.269ng) than in OnaBoNT-A (20U x 9.04pg = 0.181ng) and IncoBoNT-A (20U x 4.03 = 0.081ng).
Conclusion: No differences in light chain activity were seen between BoNT-A products. However, there were greater amounts of neurotoxin in AboBoNT-A at the recommended dose for glabellar lines than either OnaBoNT-A or IncoBoNT-A. At the recommended dose, all BoNT-A products have a similar safety profile. At approved doses, the amount of active neurotoxin in AboBoNT-A is likely to be a major factor to explain the long-lasting symptomatic relief observed in clinical studies within a well-characterised safety and tolerability profile.
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