Page 16 - PCC10

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) provide information on complete reprogramming.
‐ Genetic screening: Whole-genome sequencing PCC Stem Cells - ESHRE BCN 2018
Cell therapy
• Successful clinical translation needs consistent high quality hPSCs and theirs
derivatives that assure safety and efficiency to the patient.
• Differences in embryos or cell types of origin, reprogramming methodologies, reagents, culture conditions, differentiation protocols, create significant variability in the generated products.
• Need for robust and standardized methodology.
• Need for preclinical development, guided by the appropriate regulatory body, such as Food and Drug Administration (FDA) in US or the European MedicinesAgency (EMA) in Europe
• hPSC derivatives classified as Advanced Therapy Medicinal Products (ATMPs) (FDA and EMA).
• Production under current Good Manufacturing Practice (cGMP) conditions. PCC Stem Cells - ESHRE BCN 2018
Page 10 of 135
16