{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T20:31:44Z","timestamp":1783110704844,"version":"3.54.6"},"reference-count":44,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T00:00:00Z","timestamp":1759968000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Galderma (Uppsala, Sweden)"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Toxins"],"abstract":"<jats:p>Most botulinum toxin A (BoNT-A) products for esthetic use require reconstitution before administration. Ready-to-use relabotulinumtoxinA is a liquid manufactured using Precipitation-free Extraction and Activity-preserving, Refined Liquid (PEARL\u2122) Technology from a proprietary C. botulinum type A1 strain. We examined the in vitro characteristics of relabotulinumtoxinA. The specific BoNT-A1 potency remained consistent throughout drug substance manufacturing (1.9 \u00d7 108\u20132.2 \u00d7 108 LD50 mouse potency units\/mg of BoNT-A1, four fractions sampled). Using glabellar line (GL) on-label doses, relabotulinumtoxinA liquid product was compared with powder onabotulinumtoxinA using the following: BoNT-A1 amount based on ELISA; specific enzyme activity based on SNAP-25 cleavage by a fluorescence resonance energy transfer-based assay (BoTest\u00ae); biological activity (binding, internalization, and SNAP-25 cleavage over time) using a cell-based assay. RelabotulinumtoxinA contained more BoNT-A1 per on-label GL dose (0.27 ng) than onabotulinumtoxinA (0.18 ng), had higher enzyme activity (53 vs. 29 BoTest\u00ae units) per GL dose, and had higher specific activity per pg BoNT-A, with onabotulinumtoxinA displaying 81% of the specific activity of relabotulinumtoxinA. In vitro, relabotulinumtoxinA demonstrated higher biological activity and earlier onset of SNAP-25-cleavage than onabotulinumtoxinA. PEARLTM Technology thus produces high-quality BoNT-A1 with high specific enzyme and biological activities, which may explain the clinical performance of relabotulinumtoxinA in Phase 3 clinical trials examining treatment of GLs and\/or LCLs.<\/jats:p>","DOI":"10.3390\/toxins17100501","type":"journal-article","created":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T13:19:26Z","timestamp":1760015966000},"page":"501","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["RelabotulinumtoxinA, a Ready-to-Use Formulation Neuromodulator Manufactured with PEARL\u2122 Technology to Maintain High Biological and Specific Activity"],"prefix":"10.3390","volume":"17","author":[{"given":"Ulf","family":"St\u00e5hl","sequence":"first","affiliation":[{"name":"Galderma, 752 28 Uppsala, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilia","family":"Lekholm","sequence":"additional","affiliation":[{"name":"Galderma, 752 28 Uppsala, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emil","family":"Hamnevik","sequence":"additional","affiliation":[{"name":"Galderma, 752 28 Uppsala, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Fredriksson","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Biosciences, Uppsala University, 751 24 Uppsala, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0193-349X","authenticated-orcid":false,"given":"Sachin M.","family":"Shridharani","sequence":"additional","affiliation":[{"name":"School of Medicine, Washington University, Saint Louis, MO 63110, USA"},{"name":"LUXURGERY, New York, NY 10022, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keywan","family":"Taghetchian","sequence":"additional","affiliation":[{"name":"Smoothline, 80331 Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel L.","family":"Cohen","sequence":"additional","affiliation":[{"name":"About Skin Dermatology, Greenwood Village, CO 80111, USA"},{"name":"Department of Dermatology, University of California, Irvine, CA 92697, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8978-7932","authenticated-orcid":false,"given":"Mark S.","family":"Nestor","sequence":"additional","affiliation":[{"name":"Center for Clinical and Cosmetic Research, Aventura, FL 33180, USA"},{"name":"Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL 33125, USA"},{"name":"Department of Surgery, University of Miami Miller School of Medicine, Miami, FL 33136, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c5sa","family":"Liljegren Sundberg","sequence":"additional","affiliation":[{"name":"Galderma, 752 28 Uppsala, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,10,9]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Choudhury, S., Baker, M.R., Chatterjee, S., and Kumar, H. 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