{
  "id": 5728846,
  "title": "Collaborative study for the BINACLE assay for in vitro determination of botulinum neurotoxin activity",
  "url": "https://urgent.news/2026/09/04/collaborative-study-for-the-binacle-assay-for-in-vitro-determination",
  "topic": "science",
  "section": "Science",
  "published": "2026-09-04T00:00:00.000Z",
  "source": {
    "name": "bioRxiv",
    "slug": "biorxiv",
    "url": "https://www.biorxiv.org/content/10.64898/2026.09.01.748470v1?rss=1"
  },
  "original_language": "en",
  "account": "In a joint research endeavor, ten laboratories from around the globe collaborated to evaluate the BINACLE assay as a potential replacement for the mouse bioassay in determining the potency of botulinum neurotoxin (BoNT) products. BoNT, responsible for muscle-relaxing effects, is commonly used in clinical and aesthetic medicine, with serotypes A and B being the most relevant pharmaceutically. The mouse bioassay has long been the gold standard for potency testing, but a non-animal alternative is preferred to align with European Directive 2010/63/EU. The BINACLE assay, which assesses BoNT activity through receptor-binding and proteolytic properties, has shown promise as a viable alternative. Previous investigations revealed that this method provides reliable and sensitive activity measurements. This collaborative study aimed to determine the BINACLE assay's applicability for potency testing of pharmaceutical BoNT products. The findings indicate that the BINACLE assay facilitates reproducible relative potency determinations for BoNT/A, the serotype of most concern in pharmaceutical applications, with variations within acceptable limits. Additionally, reproducible relative potency calculations were achieved for BoNT/B, although there are suggestions for refining the BoNT/B BINACLE protocol to further improve the method's robustness. In summary, this collaborative study validates the BINACLE assay as a dependable and sensitive means of assessing BoNT product potency, supporting its use as an alternative to the mouse bioassay in line with regulatory requirements.",
  "summary": "The muscle-relaxing effects of botulinum neurotoxin (BoNT) serotypes A and B are widely utilized in clinical and aesthetic medicine. While the mouse bioassay remains the gold standard for evaluating the potency of pharmaceutical BoNT preparations, a non-animal alternative would be preferable to comply with European Directive 2010/63/EU. The Binding and Cleavage (BINACLE) assay, which measures…",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}