Manual ATMP manufacturing can be controlled at limited scale. But as demand grows, its fragility becomes structural.
It begins with operator-dependent steps and repeated transfers, where consistency relies on human execution across a process that must remain tightly controlled.
The applications presented throughout this article show how complexity changes the way sterilization processes must be developed, verified and transferred to production.
Only under these conditions, the ability to experimentally develop and industrialize sterilization processes becomes the determining factor in achieving reliable and reproducible performance.