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• W2805700238 abstract "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)." @default.
• W2805700238 created "2018-06-13" @default.
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• W2805700238 date "2018-01-01" @default.
• W2805700238 modified "2023-09-26" @default.
• W2805700238 title "Quality Assessment and Production of Human Cells for Clinical Use" @default.
• W2805700238 cites W1967144398 @default.
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• W2805700238 doi "https://doi.org/10.1007/978-1-4939-7825-0_28" @default.
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