Page 122 - ESHRE2019

Clinical grade hPSC lines and Good
Manufacturing Practice (GMP)
• Clinical grade lines need to be established according to GMP conditions in facilities with a relevant product manufacturing license under strict quality assurance and must meet with all ethical and legal requirements.
• Generation of hPSCs under GMP conditions includes
 Tissue sourcing
 hESC derivation or hiPSC generation
 Expansion
 Testing
 Storage
• Compliant GMP hESC and hiPSC have been generated
• hPSC lines established in standard conditions have been adapted to culture in GMPconditions(additional testing)
PCC Stem Cells - ESHRE Vienna 2019
Clinical grade hPSC lines and Good Manufacturing Practice (GMP) Modifications of specific components for the generation of Clinical grade hPSC
 D e r i v a t i o n a n d c u l t u r e o f h ESC :
• Avoid Xenobiotics
• Avoid immunosurgery (mechanical or laser dissection) has been described.
• Humanfibroblastsasfeedercells.
• Feeder-free conditions (Recombinant or synthetic extracellular matrices)
• Serum-freeandproducedunderGMPconditionscellgrowthmedia
• GMP enzymes for cell dissociation hiPSC reprogramming:
• Integration-free methods of reprogramming are mandatory for cell therapy: episomal vectors or Sendai virus, modified mRNA
PCC Stem Cells - ESHRE Vienna 2019
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