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Clinical grade hPSC lines and Good Manufacturing Practice (GMP)
Modifications of specific components for the derivation and culture of hESC:
• Avoid Xenobiotics
• Avoid immunosurgery (mechanical or laser dissection) has been described.
• Human fibroblasts as feeder
• Feeder-freeconditions(Recombinantorsyntheticextracellularmatrices)
• Serum-freeandproducedunderGMPconditionscellgrowthmedia
• GMP enzymes cell dissociation Regarding hiPSC reprogramming:
• Integration-free methods of reprogramming are mandatory for cell therapy: episomal vectors or Sendai virus, modified mRNA
PCC Stem Cells - ESHRE BCN 2018
Clinical grade hPSC lines and Good Manufacturing Practice (GMP)
GMP hPSC production
• Creation of first stock of vials
called Master Cell Bank (MCB)
• MCB testing and characterization
• One vial of the MCB will be used for produce future Working Cell Banks(WCB).
• Additional testing of WCB should be considered based on risk assessment.
• Undifferentiated hPSC should not be used (safety and quality considerations)
Baghbaderani, 2015
PCC Stem Cells - ESHRE BCN 2018
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