Objectives: To provide clinicians with valuable information on BoNT/A and immunogenecity to enable safe and effective treatment with BoNT/A.
Introduction: All protein-based therapeutics, such as botulinum neurotoxin type A (BoNT/A),
are potentially immunogenic and can lead to anaphylaxis, autoimmunity, or diminished or complete absence of therapeutic efficacy, especially if administered repeatedly. Therefore, the protein quantity in BoNT/A products is an important consideration when selecting products for treatment. However, essential formulation data are not always publicly accessible.
Materials / method: The neurotoxin protein content of products newly introduced in
Asia, such as (listed alphabetically) Botulax®, Meditoxin®, Nabota®, and Relatox®, was measured by sandwich enzyme-linked immunosorbent assay with antisera directed against BoNT/A compared to Xeomin®.
Results: Botulax and Nabota contained 844 and 754 pg of neurotoxin protein, with inactive neurotoxin calculated to be 103% and 81% and the potency per pg of neurotoxin was 0.118 and 0.133 U, respectively. Meditoxin and Relatox had 575 and 578 pg of neurotoxins with inactive neurotoxins of 38% and 33% and the potency per pg of neurotoxin was 0.174 and 0.173 U, respectively. However, Xeomin, which has 416 pg/vial of purified neurotoxin and 0.240 U of efficacy per pg of neurotoxin, has the lowest neurotoxin protein content and consequently the highest specific
potency compared to the four Asian BoNT/A
Conclusion: Although Botulax and Nabota had more neurotoxin than Xeomin in an equivalent
volume, they contained greater amounts of inactive neurotoxin. In addition, although Meditoxin and Relatox had slightly more neurotoxin than Xeomin, both contained greater amounts of inactive neurotoxin.
Declaraciones
¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
No
¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No
¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No
¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No
Este trabajo no cuenta con el apoyo de ningún financiamiento directo o indirecto. El autor asume plena responsabilidad sobre el mismo.