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Characterisation for clinical application
Quality and safety control
‐ Sterility testing: more exhaustive than standard routine microbiological tests performed for research.
‐ Virological testing: Detection of viral agents as HBsAg antigen, anti-HBc antibodies, anti hepatitis C antibodies, anti-ViH antibodies, DNA VHB, RNA VIH-1, RNA VHC, TPHA (syphilis antibodies), Chagas and HTLV-I/II.
‐ DNA methylation analysis: (hiPSC) information on complete reprogramming.
‐ Genetic screening: Whole-genome sequencing PCC Stem Cells - ESHRE Vienna 2019
Clinical grade hPSC lines and Good Manufacturing Practice (GMP)
GMP conditions include 5 fundamental pillars
‐ Tra c e a b ility : Set of measures, actions and procedures to identify and register each product from its origin to the final destination.
‐ Documentation: SOPs. Description of activities and processes. Registration and verification of activities.
‐ Validation: Verification of manuphacturing process.
‐ Quality control: Quality management system (QMS) and Quality Assurance (QA).
‐ Tra ining : Training and continuous qualification for all staff members in production processes and quality regulations.
PCC Stem Cells - ESHRE Vienna 2019
Overview of intra and inter-organisational relationships in the establishment of a GMP hESC production capacity
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