{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T17:03:12Z","timestamp":1782925392313,"version":"3.54.5"},"reference-count":15,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2023,12,5]],"date-time":"2023-12-05T00:00:00Z","timestamp":1701734400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Revance Therapeutics"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Toxins"],"abstract":"<jats:p>DaxibotulinumtoxinA-lanm for injection (DAXI) is a unique US Food and Drug Administration-approved product comprising daxibotulinumtoxinA and a stabilizing excipient peptide (RTP004). DAXI has a longer-labeled shelf life (72 h) following reconstitution than other botulinum toxin type A products. Here, we report the stability and microbial control of reconstituted DAXI when stored at 2 \u00b0C\u20138 \u00b0C over a period of 36 days (Study 1) and 7 days (Study 2) following reconstitution with unpreserved or preserved saline. The pH and biological activity of reconstituted DAXI in the 50 U\/vial and 100 U\/vial formats remained stable at the final assessed time point in both preserved and unpreserved saline when refrigerated (2 \u00b0C\u20138 \u00b0C). No changes in recoverable 150 kDa neurotoxin (measured by enzyme-linked immunosorbent assay) were observed over 6 days of refrigeration. Bacterial growth or pathogen proliferation was not observed in DAXI reconstituted in preserved or unpreserved saline in both studies.<\/jats:p>","DOI":"10.3390\/toxins15120683","type":"journal-article","created":{"date-parts":[[2023,12,5]],"date-time":"2023-12-05T08:09:17Z","timestamp":1701763757000},"page":"683","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Biochemical Stability and Microbial Control of Reconstituted DaxibotulinumtoxinA-lanm for Injection"],"prefix":"10.3390","volume":"15","author":[{"given":"Kimberlee","family":"Ellis","sequence":"first","affiliation":[{"name":"Revance Therapeutics, Inc., Newark, CA 94560, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thai","family":"Thach","sequence":"additional","affiliation":[{"name":"Revance Therapeutics, Inc., Newark, CA 94560, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5488-6594","authenticated-orcid":false,"given":"Conor J.","family":"Gallagher","sequence":"additional","affiliation":[{"name":"Revance Therapeutics, Inc., Newark, CA 94560, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,12,5]]},"reference":[{"key":"ref_1","first-page":"31","article-title":"Comparison and Overview of Currently Available Neurotoxins","volume":"7","author":"Walker","year":"2014","journal-title":"J. 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Proceedings of the TOXINS 2021, Virtual.","DOI":"10.1016\/j.toxicon.2020.11.410"}],"container-title":["Toxins"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6651\/15\/12\/683\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:33:31Z","timestamp":1760132011000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6651\/15\/12\/683"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,5]]},"references-count":15,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["toxins15120683"],"URL":"https:\/\/doi.org\/10.3390\/toxins15120683","relation":{},"ISSN":["2072-6651"],"issn-type":[{"value":"2072-6651","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12,5]]}}}