Lise Morizur: Research engineer (CECS)
Léa Lesueur: Associate engineer (CECS)
The unique properties of self-renewal and differentiation of human pluripotent stem cell (hPSCs) make them attractive candidates for disease modeling and drug screening. Large-scale manufacture of hPSCs and their derivative is also prerequisite to their use in clinical applications such as regenerative medicine. It has however proved particularly challenging due to process variation as well as quality standards for clinical translation. The development of automated bioprocesses is thus key to achieve cost-effective, controlled and standardized cell production.
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.