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Updated: Jul 11, 2025

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基于芯片的数字PCR作为mRNA药物中残留DNA的直接量化方法

Wenchao Fan¹, Lan Zhao¹, Lei Yu¹

¹Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, No. 2, Tiantan Xili, Dongcheng District, Beijing 100050, China.

Journal of pharmaceutical and biomedical analysis

|November 12, 2023

概括

数字PCR (dPCR) 准确量化了mRNA疫苗中的残留DNA. 这种敏感的方法通过检测污染物来确保生物产品的安全.

科学领域:

生物技术是生物技术.
分子生物学分子生物学
分析化学分析化学

背景情况:

外源DNA残留物是生物产品中常见的污染物,需要严格监测和清除以确保安全.
数字PCR (dPCR) 是一种敏感和特定的DNA量化技术,但其在mRNA药物残留DNA检测中的应用需要进一步调查.

研究的目的:

建立和验证用于检测mRNA疫苗中的残留DNA的数字PCR (dPCR) 方法.
评估用于剩余DNA量化开发的dPCR方法的性能特征.

主要方法:

为两个不同的mRNA疫苗配方量身定制的dPCR试验的开发.
验证dPCR方法的线性,精度,准确性和特异性.
评估封装和脱硫试剂的干扰.

主要成果:

已建立的dPCR方法显示了广泛的线性范围,良好的精度和高精度.
开发的方法表现出特异性,不受常见的mRNA疫苗配方成分的影响.
发现dPCR试验简单,快速,对残留DNA检测高度敏感.

结论:

数字PCR (dPCR) 是一种适合和准确的技术,用于量化mRNA药物中的残留DNA.
已建立的dPCR方法提供了一种可靠的工具,以确保基于mRNA的生物产品的安全.

关键词:

基于芯片的数字PCR.剩余的DNA是剩余的DNA.mRNA药物 mRNA药物是一种药物.

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相关概念视频

Real Time RT-PCR

Real Time RT-PCR

Real-time reverse transcription-polymerase chain reaction, or Real-time RT-PCR, is an analytical tool used to determine the expression level of target genes. The method involves converting mRNA to complementary DNA with the help of an enzyme known as reverse transcriptase, followed by the PCR amplification of the cDNA. These two processes can be performed simultaneously in a single tube or separately as a two-step reaction.
The real-time quantification of the number of amplified products is...