Page 123 - ESHRE2019
P. 123
Clinical grade hPSC lines and Good Manufacturing Practice (GMP)
GMPhPSC production
• Creation of first stock of vials called Master Cell Bank (MCB)
• MCB testing and characterisation
• One vial of the MCB will be used to produce future Working Cell Banks (WCB).
• Additional testing of WCB should be based on risk assessment.
• Undifferentiated hPSC should not be used (safety and quality considerations)
Baghbaderani, 2015
PCC Stem Cells - ESHRE Vienna 2019
Schematic depicting the timeline and stepwise procedure for cGMP-compliant fibroblast isolation from patient skin biopsies and subsequent generation, clonal expansion and analysis of patient-derived iPSCs.
Schematic showing the timeline and stepwise procedure for cGMP-compliant
three-dimensional differentiation of patient iPSCs and the production of iPSC-derived retinal organoids.
cGMPproduction of patient-specific iPSCs and photoreceptor precursor cells to treat retinal degenerative blindness. Wiley 2018
PCC Stem Cells - ESHRE Vienna 2019
118
PRECONGRESS COURSE 13 I VIENNA, AUSTRIA – 23 JUNE 2019 121
