Which ISO class is mandated for cGMP facility development to culture adipose-derive human Mesenchymal Stem Cells (hMSCs)?

19 September 2022 0 8K Report

For manufacturing cGMP-compliant hMSCs which ISO class (ISO 100 or 1000 or any other standards) cleanroom is needed? The hMSCs will be manufactured for autologous therapy of patients.

Please inform the minimum/must-have ISO Class along with the best one for stem cell manufacturing.

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