Review highlights the immunomodulatory effects of double-stranded RNA impurities in mRNA vaccines, suggesting the need for standardized detection methods and quality-by-design manufacturing.
dsRNA as a critical quality attribute (CQA), the structural heterogeneity of it (including length and structure) and its precise immunomodulatory mechanisms affecting vaccine safety are poorly understood. Regulatory authorities have not released specific standards for dsRNA. Additionally, there is a lack of comparative analysis data on different corporate testing methods. Therefore, to ensure the safety of dsRNA containing mRNA vaccines and improve mRNA-based platforms, it is of great significance to establish standardized detection methods and standards for dsRNA; to design mRNA production with low dsRNA impurities by adopting the quality by design (QbD) approach; and to evaluate the immune stimulation mechanism of dsRNA impurities in mRNA vaccines.
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Liu et al. (2025) studied this question.
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