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在mRNA疫苗中定量DNA杂质的客观度

Stefanie Kaiser¹, Steffen Kaiser², Jenny Reis³

¹Institute of Pharmaceutical Chemistry, Goethe-University Frankfurt, Max-von-Laue-Str. 9, 60438 Frankfurt/Main, Germany.

|March 22, 2025

概括

调查了最近关于mRNA疫苗中高DNA杂质的说法. 我们的发现证实了DNA:RNA比率与已批准的疫苗规格保持一致,驳斥了之前夸张的杂质水平.

科学领域:

生物技术和制药科学生物技术和制药科学
分子生物学和遗传学

背景情况:

使用脂质纳米粒子 (LNP) 输送的信使RNA (mRNA) 疫苗彻底改变了疫苗开发.
在体外转录 (IVT) 中的剩余等离子体DNA是mRNA疫苗制造过程中的与过程相关的杂质.
关于mRNA疫苗中DNA杂质水平升高的担忧在社交媒体上被提出.

研究的目的:

调查和复制mRNA疫苗中显著高DNA杂质的说法.
准确量化批准的mRNA疫苗产品中的DNA和RNA度.

主要方法:

使用Qubit光测量对RNA和DNA度的量化.
通过液态染色学-质谱学 (LC-MS/MS) 进行分析,以进行精确的测量.
应用直角方法来验证发现.

主要成果:

确认可复制DNA:RNA质量比为1:1000,符合产品规格.
534倍高的DNA杂质的说法被发现是不正确的,归因于高的RNA/脂质度.
在BNT162b2 (Comirnaty) 和mRNA-1273 (Spikevax) 中的DNA杂质水平与批准的规格保持一致.

结论:

经批准的mRNA疫苗中DNA杂质的度符合已确定的安全规范.
此前关于mRNA疫苗中过度DNA污染的报道没有得到本次调查的支持.
该研究验证了当前mRNA疫苗制造工艺在DNA杂质方面的安全性.

关键词:

它们是DNA DNA DNA DNA.含有DNA杂质的杂质.方法论方法论方法论这是一个RNARNARNARNARNA.这就是SARS-CoV-2病毒.在mRNA疫苗的使用中.

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