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标准在疫苗开发中的可用性和使用
Michael Selorm Avumegah1, Giada Mattiuzzo2, Anna Särnefält3
1Coalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway. selorm.avumegah@cepi.net.
NPJ vaccines
|June 30, 2023
概括
参考材料和国际标准对于疫苗开发和制造至关重要. 它们的使用确保了准确的免疫测试校准和可靠的疫苗反应评估,这对公共卫生至关重要.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 免疫学 免疫学 免疫学
- 生物技术是生物技术.
背景情况:
- 参考材料对于在疫苗开发中校准测试至关重要.
- 随着COVID-19的流行,人们需要强大的免疫检测标准来评估疫苗的反应.
- 标准对于控制疫苗制造工艺和确保产品质量也至关重要.
研究的目的:
- 在整个疫苗开发生命周期中倡导将参考材料和校准纳入国际标准.
- 强调为成功的化学,制造和控制 (CMC) 战略需要标准化测试.
- 为世界卫生组织 (WHO) 对CEPI优先病原体的国际抗体标准的可用性提供信息.
主要方法:
- 这篇视角论文回顾了参考材料在测试开发中的关键作用.
- 它讨论了对国际标准的校准测试的重要性.
- 它强调了世卫组织特定的国际抗体标准的可用性.
主要成果:
- 标准化测定和参考材料是可靠的疫苗表征所必需的.
- 从临床前开发到对照测试的参考材料是必不可少的.
- 世卫组织的国际抗体标准可用于特定的病原体.
结论:
- 采用参考材料和国际标准对于强大的疫苗开发和制造至关重要.
- 标准化确保准确评估疫苗的疗效和制造的一致性.
- 世卫组织标准的可用性支持全球为优先病原体开发疫苗的努力.
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