| Autor: |
Fraser L; RoslinCT, NINE Edinburgh Bioquarter, Edinburgh, UK., Bruce K; Censo Biotechnologies, Roslin Biocentre, Roslin, Midlothian, UK., Campbell JM; Scottish National Blood Transfusion Service, The Jack Copland Centre, Edinburgh, UK., De Sousa PA; Roslin Cells Ltd, Roslin Biocentre, Roslin, UK. Paul.desousa@ed.ac.uk.; Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK. Paul.desousa@ed.ac.uk. |
| Abstrakt: |
Cell transplantation therapy aspires to repair and restore lost function while minimizing the risk of harm. The potential for harm arises from cell instability, variability, inappropriate behavior, and/or transmission of adventitious pathogens. Quality assured and controlled assessment and production of human cells for clinical use ensures that the risk of harm is minimized. Application of quality standards requires thorough planning and consultation with regulatory authorities on process and product specifications, as early as possible at the research and development (R&D) stage. Here we outline considerations applicable to all human cells in relation to regulatory governance, the route to the clinic and Cell Therapy Product (CTP) characterization, with special emphasis on human pluripotent stem cells (hPSC). |
