3Rs Webinar on Botulinum Neurotoxin Testing

As part of the 3Rs Training Webinar Series led by Dr. Kathrin Herrmann, Director of the Education Program at the Center for Alternatives to Animal Testing (CAAT), Justine C. Watkins from Utrecht University’s Faculty of Veterinary Medicine will present her team’s latest research on replacing animal use in botulinum neurotoxin (BoNT) testing. Botulinum neurotoxin (BoNT), commonly referred to as 'Botox', is widely used in medical and aesthetic applications across the globe. As a biological product, BoNT requires rigorous batch potency testing to ensure safety, and is currently reliant on the ethically and scientifically contentious Mouse Lethality Bioassay (MLB). Despite severe mouse suffering, the reproducibility crisis, and translatability issues of this Lethal Dose (LD50) test, its use persists due to regulatory inertia and other systemic barriers. Recent advancements in new approach methodologies (NAMs), particularly cell-based assays (CBAs), offer promising non-animal alternatives for regulatory potency testing. This webinar, inspired by the speaker’s recent publication “Botulinum neurotoxin: Tracking the transition from lethal dose to in vitro models”, aims to provide an update on the transition to NAMs, primarily focusing on European institutions as key players in the production and testing of BoNT products. This webinar will explain why potency testing is a regulatory requirement for BoNT products, describe cell-based alternatives to the MLB, unpack the current distribution of BoNT products in Europe and explore the use of mice for this purpose in the European Union and United Kingdom. The presenter will discuss their current understanding of the the number of mice used per year for BoNT alone and describe their findings from the analysis of over 31 Non-Technical Summaries (NTSs) from testing facilities across the UK, Germany, and Ireland. Lastly, the speaker will highlight some actionable insights to overcome socio-technical barriers to implementing MLB alternatives. Justine Watkins is a PhD Candidate from Utrecht University working on the transition to animal-free innovations in collaboration with the Safety assessment through Animal Free Evolution (SAFE) consortium. She obtained her MSc in Biology from Radboud University specializing in animal physiology and behaviour. She obtained her Bachelor's of Science from University College Roosevelt, Netherlands, where she obtained an interdisciplinary degree majoring in biomedical and environmental sciences, with coursework in social sciences and arts and humanities. Above all else she has a passion for animal-related topics and strives to center her research and future career around the interests of non-human animals.