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  • Title: Viral risk mitigation for Mammalian cell culture media.
    Author: Weaver B, Rosenthal S.
    Journal: PDA J Pharm Sci Technol; 2010; 64(5):436-9. PubMed ID: 21502048.
    Abstract:
    Adventitious viral contamination in mammalian cell culture manufacturing facilities can lead to loss of product due to regulatory concerns regarding potential health risks. These events can also result in manufacturing shutdowns for extended periods of time. Numerous measures are currently taken to minimize these risks. Nonetheless, raw materials remain a high-risk entry point for viral contamination of mammalian cell cultures. Two virucidal technologies, ultraviolet radiation in the C band and high-temperature short-time pasteurization, were tested for the treatment of mammalian cell culture media. The results demonstrated no impact to the cell culture process or the quality of the products produced at the chosen dosage while providing robust viral protection.
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