Abstract：
Animal testing has long been integral to the development of biologicals, including vaccines. The use of animals can provide important information on potential toxicity, insights into their mechanism of action, pharmacokinetics and dynamics, physiologic distribution, and potency. However, the use of these same methods is often adopted into the post-licensure phase of the product life cycle for the monitoring of product qualities, such as potency or safety, as part of their routine batch release. The UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) and the World Health Organization (WHO) are collaborating on a project to review animal-based testing methods described in WHO manuals, guidelines and recommendations for biologicals to identify where updates can lead to a more harmonised adoption of 3Rs principles (i.e. Replacement, Reduction, and Refinement of animal tests) in batch release testing requirements. An international working group consisting of more than 30 representatives from pharmaceutical and biotechnology companies, national control laboratories and regulatory bodies is performing this review. This project aims to address concerns about inconsistencies in the guidance for the scientifically justified use of animal methods required for the post-licensure quality control and batch release testing of biologicals, and the near absence of recommendations for the application of 3Rs principles within the relevant guidelines. Improved adoption of 3Rs principles and non-animal testing strategies will help to reduce the delays and costs associated with product release testing and help support faster access to products by the global communities who need them most urgently.
摘要：
动物测试长期以来一直是生物制品发展的组成部分，包括疫苗。使用动物可以提供有关潜在毒性的重要信息，对它们作用机制的洞察，药代动力学和动力学，生理分布，和效力。然而,在产品生命周期的许可后阶段，通常采用这些相同的方法来监测产品质量，如效力或安全性，作为其常规批量发布的一部分。英国国家置换中心，精炼,和减少研究中的动物（NC3Rs）和世界卫生组织（WHO）正在合作开展一个项目，以审查WHO手册中描述的基于动物的测试方法，生物制品的指南和建议，以确定哪些更新可以导致更协调地采用3Rs原则(即替换，Reduction,和动物试验的细化)在批量释放试验要求中。一个由30多名制药和生物技术公司代表组成的国际工作组,国家控制实验室和监管机构正在进行这项审查。该项目旨在解决有关生物制品许可后质量控制和批量释放测试所需的科学合理使用动物方法的指南不一致的问题，以及几乎没有在相关准则中应用3Rs原则的建议。改善3Rs原则和非动物测试策略的采用将有助于减少与产品发布测试相关的延迟和成本，并有助于支持最迫切需要产品的全球社区更快地获取产品。
