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◆ Biologicals : journal of the International Association of Biological Standardization2026-08-06

Report of the international conference on animal testing replacement for vaccines: A one health view on global outlook and future strategy.

Laura Viviani, Evelin Balbino, Meenu Batolar, Jay Bolden, Sarawut Boonsuk, Badiaa Bouzya, Mihaela Buda, Jean-Michel Chapsal, Emmanuelle Coppens, Pradip Das, Fitra Delviona, Blaise Descampe, Alan Fauconnier, Sunil Goel, Juliana Gutierrez-Mazariegos, Bernhard Illes, Masaaki Iwaki, Muthusamy Kalaivani, Naree Ketusing, Manjari Lal, Dianliang Lei, Joe Little, Kutub Mahmood, Javier Martin, Laure Martinez, Catherine Milne, Mercy Mvundura, Ole F Olesen, Katarzyna Osetek-Müller, Lorenzo Del Pace, Sampa Pal, In-Sook Park, Corinne Philippe, Colleen Pike, Luca Porfiri, Nakorn Premsri, Dieter Pullirsch, Charles Sandy, Gautam Sanyal, Kota Sato, Heidemarie Schindl, Sarah Sheridan, Juliana Galvão, Rabindra Prasad Singh, Dean Smith, Paul Stickings, Danilo Tagle, Lorenzo Tesolin, Joris Vandeputte, Janette Turner

原始摘要(英文原文)· Original abstract
The transition toward non-animal methods for vaccine quality control has accelerated in recent years, driven by scientific advances and evolving regulatory expectations. To assess the current status of replacing animal-based methods, international stakeholders from regulatory authorities, industry, and public health institutions convened in Bangkok, Thailand from 2 to 4 December 2025 for the conference "Animal Testing Replacement for Vaccines: A One Health View - Global Outlook and Future Strategy," organized by Animal-Free Safety Assessment Collaboration and the International Alliance for Biological Standardization. This report synthesizes key discussions from the meeting, including advancements in in vitro potency, safety, and pyrogenicity testing; challenges associated with validation and global regulatory acceptance; access to critical reagents and reference standards; implementation of reliance and work-sharing models; and capacity building for national control laboratories across human and veterinary sectors. Despite recent progress in some areas, significant barriers remain, including fragmented regulatory requirements, limited access to reference standards, and inconsistent validation and implementation pathways across regions and sectors. Collectively, the outcomes underscore the need for coordinated international action to enable broader adoption of scientifically robust, non-animal testing strategies for quality control of vaccines.
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Report of the international conference on animal testing replacement for vaccines: A one health view on global outlook and future strategy. — 科研速览 Science Skim