We have developed at I-Stem a fully automated bioproduction platform for research applications (non-GMP) based on the use of CompacT SelecT technology for the amplification and differentiation of hPSCs under feeder-free adherent culture conditions. Process performance and variability are monitored throughout scale out to prevent deviations from specification limits. Cell suspensions are automatically dispensed into cryovials (Fill-it) and frozen using a controlled-rate freezing equipment chamber (Cryomed). Importantly, all cell banks undergo appropriate quality testing according to international guidelines – such as phenotypic characterization, genomic stability and microbiological testing – to ensure they meet release criteria.

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