This two-day workshop, co-sponsored by NICEATM and IABS-NA, brought together over 60 international scientists from government, academia, and industry to advance alternative methods for human and veterinary Rabies Virus Vaccine (RVV) potency testing. On day one, workshop presentations focused on regulatory perspectives related to in vitro potency testing, including recent additions to the European Pharmacopoeia (5.2.14) that provide a scientific rationale for why in vivo methods may be less suitable for vaccine quality control than appropriately designed in vitro methods. Further presentations reviewed the role of the consistency approach to manufacturing and vaccine batch comparison to provide supportive data for the substitution of existing animal-based methods with in vitro assays. In addition, updates from research programs evaluating and validating RVV glycoprotein (G) quantitation by ELISA as an in vitro potency test were presented. On the second day, RVV stakeholders participated in separate human and veterinary vaccine discussion groups focused on identifying potential obstacles or additional requirements for successful implementation of non-animal alternatives to the in vivo potency test. Workshop outcomes and proposed follow up activities are discussed herein.

这个为期两天的研讨会由NICEATM和IABS-NA共同赞助，汇集了来自政府，学术界和工业界的60多位国际科学家，以推动人类和兽医狂犬病病毒疫苗（RVV）效力测试的替代方法。在第一天，研讨会的演讲着重于与体外效价测试相关的监管观点，包括最近加入的《欧洲药典》（5.2.14），为为何体内方法可能不适用于疫苗质量控制而不是经过适当设计提供了科学依据。体外方法。进一步的演讲回顾了一致性方法在生产和疫苗批次比较中的作用，以为体外试验替代现有的基于动物的方法提供支持性数据。此外，还介绍了通过ELISA评价和验证RVV糖蛋白（G）定量作为体外效价测试的研究计划的更新。第二天，RVV利益相关者参加了单独的人类和兽医疫苗讨论小组，重点讨论了成功实施体内试验非动物替代品的潜在障碍或其他要求。本文讨论了研讨会的成果和拟议的后续活动。