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与腺病毒载体疫苗相关的虚假阳性结果强调了消除异常毒性测试的监管必要性

Ryan Meng¹, Mark van Ooij², Yali Li³

¹Preclinical Sciences and Translational Safety, Janssen (China) Research & Development, China.

Regulatory toxicology and pharmacology : RTP

|April 1, 2024

概括

异常毒性测试 (ATT) 不适用于生物制剂和疫苗. 标准ATT条件导致错误阳性,使其不适合对疫苗和基因疗法的批量释放测试.

科学领域:

药理学和毒理学药理学和毒理学
生物技术是生物技术.
疫苗学疫苗学疫苗学

背景情况:

异常毒性测试 (ATT) 是生物制剂和疫苗的标准质量控制措施.
人们对ATT在批量释放测试中的适用性和可靠性存在担忧.
基于腺病毒载体的产品和基因疗法为ATT验证带来了独特的挑战.

研究的目的:

确定一种最佳的实验设计,用于对基于腺病毒载体的疫苗产品的异常毒性测试 (ATT).
在标准药库条件下识别和减轻导致ATT假阳性结果的因素.
提供支持将ATT作为强制性批量释放试验的证据.

主要方法:

根据药典指南,在小鼠和豚鼠中进行异常毒性测试 (ATT).
修改了ATT协议,以评估不同剂量量和病毒颗粒 (VP) 量的影响.
使用基于腺病毒载体的疫苗产品作为模型系统.

主要成果:

标准的药典ATT条件,包括人体相关剂量 (VPs) 的腹腔内 (IP) 剂量,产生了假阳性结果.
这些错误的阳性结果并非归因于外来产品污染物,而是归因于测试方法.
这些发现凸显了ATT对于基于腺病毒载体的产品和类似的基因疗法的不合适性.

结论:

异常毒性测试 (ATT) 不是适用于生物制品,疫苗和基因疗法的批量释放测试,因为它倾向于假阳性.
目前的ATT方法导致不必要的动物使用,并从关键研究中转移资源.
监管机构应该永久取消ATT作为全球强制性批量释放测试.

关键词:

异常毒性测试异常的毒性测试亚地诺病毒疫苗亚地诺病毒疫苗几内亚猪几内亚猪是什么意思我们的老鼠是老鼠.药典中的药典.造成混的因素.

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