What must be the Classification (particle count) and negative pressure for virus lab for clinical grade production of viral vectors?

Sushilkumar Devidasrao Ramdasi @Sushilkumar-Ramdasi

31 January 2019 1 1K Report

Hi,

Please guide me on area classification and negative pressure specifications for cGMP laboratory for the production of clinical grade viral vectors.

Also, please help me with relevant regulatory guidelines.

Thanking you in anticipation.

Paolo Sanesi

To start please read this official guideline: https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf?ua=1

Let me know

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