Regulatory Open Forum

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  • 1.  Grade A clean room for Cell & Gene therapy

    Posted 02-Dec-2020 09:39

    Dear All,

    Can a BSC, bio safety cabinet, in Grade B room be used for GMP production of cell & gene therapy, which requires Grade A clean room?

    Thanks,
    Sung



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    Sung Nyeo Shim
    Consultant
    Chicago IL
    United States
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  • 2.  RE: Grade A clean room for Cell & Gene therapy

    Posted 12-Dec-2020 11:14
    Hi Sung,

    Why do you ask the obvious question?

    Normally it is not a good idea to deviate from your GMP requirement for room classification but I like to hear more the reason to ask?

    Thanks.

    Gene

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    Jingdong Zhu
    Independent Consultant
    Basking Ridge NJ
    USA
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    Original Message


  • 3.  RE: Grade A clean room for Cell & Gene therapy

    Posted 12-Dec-2020 15:18
    I don’t think that’s even acceptable per regulatory standards. Even more so for autologus cell therapy products, when finished product sterility results won’t be available at the time of patient infusion of genetically modified cells.

    ---------------------------------
    Deep Shah, MS
    Global Regulatory Affairs CMC
    Seattle, WA
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    Original Message


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