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Residual DNA in Vaccines

The presence and regulation of residual DNA in biological products, specifically vaccines, including limits and testing methods.

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Jan 29, 2026
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What does regulatory guidance say about allowable residual DNA in mRNA‑based vaccines and how is it controlled?

Regulatory guidance from major authorities sets explicit precautionary limits on in biological products—commonly a ceiling of 10 nanograms of DNA per purified vaccine dose—and requires validated analy...