Dr. Bateman answers IOM questions from the community: Part 1
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FDA Guidelines for Vaccine Production using Cell Culture

Discussion in 'Other Health News and Research' started by JT1024, Oct 15, 2011.

  1. JT1024

    JT1024 Senior Member

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    Massachusetts
    Interesting post...

    http://blogs.terrapinn.com/vaccinenation/2011/09/15/fda-discusses-cell-culture-screening-technology/

    The FDA had been looking into screening technologies that address one of the main concerns about vaccine production being carried out by cell lines and not by traditional egg-based methods:
    the risk of contamination of the final product

    The FDA has set strict guidelines which state that for a cell line to be qualified all materials being used for vaccine production need to be screened for all known and unknown pathogens, a tough task!

    Dr Arifa Khan, Senior Investigator, CBER, FDA will be speaking at the World Vaccine Cell Culture Congress next year in Washington D.C. about these concerns, and discussing their studies into the screening technologies available today.

    Here is the link to the actual FDA guidelines: http://www.fda.gov/downloads/biolog...yinformation/guidances/vaccines/ucm202439.pdf
     

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