Forum Topic: Residual DNA Testing

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Residual DNA Testing

Biopharmaceutical products, such as therapeutic proteins and vaccines, are produced by fermentation using either bacterial or eukaryotic cells. The cells used to produce biopharmaceuticals can be sources of a range of complex, heterogeneous, and potentially unsafe impurities, and host cell DNA is among these. The residual host cell DNA may result in tumors or adverse reactions. Besides, cells used to produce biopharmaceuticals may possibly carry viruses or harbor harmful nucleic acid, and the residual DNA in a given biopharmaceutical product may be infectious. Therefore, some regulatory agencies have allowed a target of 100 pg or less of residual DNA per dose in biopharmaceuticals, and levels up to 10 ng of residual DNA per dose may be considered, depending on the source of the residual DNA and the product's route. https://www.creative-biogene.com/Services/Residual-DNA-Testing.html

This topic was started by wendy wilson.

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