Abstract Committee Review

Abstract TitleNonclinical Comparison of IncobotulinumtoxinA, Coretox and LanbotulinumtoxinA
First AuthorDr. Stefanie Honndorf
StatusApproved
Comments to Author

Please include standard deviations and statistical information for the bioactivity assay and ELISA. Please also add units to the ELISA results.

Of note, it is curious that INCO contained 116 U / 100 U label presumably using the same assay that is used for unit determination during DP production.

Comments from Author

thank you for the comments on abstract 0096 which we have included in the revised version attached. Changes in the abstract are in track changes mode and the line numbers provided underneath in this email refer to the track changes version. As we agree with all comments the responses in red here are fyi only.

 

  • Please include standard deviations and statistical information for the bioactivity assay and ELISA. Please also add units to the ELISA results. We have added standard deviations and statistical information for bioactivity and ELISA results in Results lines 2-4 and 9-16.
  • Of note, it is curious that INCO contained 116 U / 100 U label presumably using the same assay that is used for unit determination during DP production. Correct, but all BoNT/A products are specified with 80-125% bioactivity according to the USP. Results within this range are in spec and differences to other NT products may even be significant but in spec. However, remarkable are results beyond the specification frame which need to be carefully discussed in light of the assays used and the conditions. This discussion is core of the poster.
ReviewerPellett