Abstract：
There are rational arguments to replace existing in vivo potency and safety assays for batch release testing of vaccines with more advanced non-animal techniques to measure critical quality attributes. However, the introduction of in vitro alternatives to replace in vivo release assays of authorized vaccines is challenging.
This report describes the hurdles encountered in substituting in vivo assays and ways to overcome these and provides arguments why more advanced in vitro alternatives are superior, not only as a tool to monitor the quality of vaccines but also from a practical, economical, and ethical point of view. The rational arguments provided for regulatory acceptance can support a strategy to replace/substitute any in vivo batch release test if an appropriate non-animal testing strategy is available.
For several vaccines, in vivo release assays have been replaced leading to an optimized control strategy. For other vaccines, new assays are being developed that can expect to be introduced within 5-10 years. From a scientific, logistical, and animal welfare perspective, it would be beneficial to substitute all existing in vivo batch release assays for vaccines. Given the challenges related to development, validation, and acceptance of new methods, and considering the relatively low prices of some legacy vaccines, this cannot be done without government incentives and supportive regulatory authorities from all regions.
This report describes the hurdles encountered in substituting in vivo assays and ways to overcome these and provides arguments why more advanced in vitro alternatives are superior, not only as a tool to monitor the quality of vaccines but also from a practical, economical, and ethical point of view. The rational arguments provided for regulatory acceptance can support a strategy to replace/substitute any in vivo batch release test if an appropriate non-animal testing strategy is available.
For several vaccines, in vivo release assays have been replaced leading to an optimized control strategy. For other vaccines, new assays are being developed that can expect to be introduced within 5-10 years. From a scientific, logistical, and animal welfare perspective, it would be beneficial to substitute all existing in vivo batch release assays for vaccines. Given the challenges related to development, validation, and acceptance of new methods, and considering the relatively low prices of some legacy vaccines, this cannot be done without government incentives and supportive regulatory authorities from all regions.
摘要：
■有一些合理的论点，可以用更先进的非动物技术来代替现有的体内效力和安全性测定，用于疫苗的批量释放测试，以测量关键的质量属性。然而,引入体外替代品来替代授权疫苗的体内释放测定是具有挑战性的。
■本报告描述了在替代体内测定法时遇到的障碍以及克服这些障碍的方法，并提供了为什么更先进的体外替代品更优越的论点，不仅作为监测疫苗质量的工具，经济和伦理的观点。如果适当的非动物测试策略可用，则为监管机构接受提供的合理论据可以支持替换/替代任何体内分批释放测试的策略。
■对于几种疫苗，体内释放测定已被取代，导致优化的控制策略。对于其他疫苗，正在开发新的检测方法，预计将在5-10年内推出。从一个科学,后勤和动物福利的观点，用所有现有的体内分批释放试验代替疫苗将是有益的。鉴于与发展有关的挑战，新方法的验证和接受，考虑到一些传统疫苗的相对较低的价格，没有所有地区的政府激励措施和支持的监管机构，这是不可能做到的。
■本报告描述了在替代体内测定法时遇到的障碍以及克服这些障碍的方法，并提供了为什么更先进的体外替代品更优越的论点，不仅作为监测疫苗质量的工具，经济和伦理的观点。如果适当的非动物测试策略可用，则为监管机构接受提供的合理论据可以支持替换/替代任何体内分批释放测试的策略。
■对于几种疫苗，体内释放测定已被取代，导致优化的控制策略。对于其他疫苗，正在开发新的检测方法，预计将在5-10年内推出。从一个科学,后勤和动物福利的观点，用所有现有的体内分批释放试验代替疫苗将是有益的。鉴于与发展有关的挑战，新方法的验证和接受，考虑到一些传统疫苗的相对较低的价格，没有所有地区的政府激励措施和支持的监管机构，这是不可能做到的。
