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    Stem cell products need to be processed in an aseptic way since it is not possible to sterilize them in the final stage of production.

    According to EU regulation addressed in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) Annex 1: Manufacture of Sterile Medicinal Products, a clean room environment operated by trained personnel following strict procedures contributes to this aim.  

    Hence, all efforts are made to minimise the risk of contamination (HVAC, pressure differentials, cleaning procedure, monitoring programmes, etc.) are in place.