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Article summary:
1. Animal cell substrates are commonly used in the manufacture of biological products, and trace/low quantity of DNA originating from the cell substrate may remain in the final product.
2. Guidelines defining acceptable levels of residual host cell DNA (rcDNA) in biological products have evolved over time, with the World Health Organization (WHO) suggesting a limit of ≤100 pg per parenteral dose in 1987, and later increasing it to ≤10 ng per parenteral dose.
3. Various methods are available for quantifying rcDNA, including membrane hybridization and Threshold® assays; however, these methods have associated variability and limitations.
Article analysis:
This article provides an overview of the performance of residual host cell DNA assays for viral vaccines produced in Vero cells. The article is well-written and provides a comprehensive overview of the various regulatory guidelines related to rcDNA content in biological products, as well as an overview of the different methods available for quantifying rcDNA. The article is reliable and trustworthy as it cites relevant sources throughout its text, providing evidence to support its claims. Furthermore, it does not appear to be biased or one-sided; rather, it presents both sides equally by noting potential risks associated with rcDNA content as well as possible solutions such as using DNA alkylating agents or reducing rcDNA content further through manufacturing processes. However, there are some points that could be explored further such as potential biases associated with certain methods used for quantifying rcDNA or unexplored counterarguments related to potential risks associated with rcDNA content. Additionally, more evidence could be provided to support certain claims made throughout the text such as those related to oncogenicity risk posed by rcDNA from continuous cell lines or those related to oral administration of DNA fragments being absorbed approximately 10,000-fold less efficiently than parenterally administered DNA fragments. All in all, this article is reliable and trustworthy overall but could benefit from further exploration into certain topics mentioned throughout its text.