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1) "Cells at end of their in vitro cell age" , : "In Vitro Cell Age - A measure of the period between thawing of the MCB vial(s) and harvest of the production vessel measured by elapsed chronological time in culture, population doubling level of the cells or passage level of the cells when subcultivated by a defined procedure for dilution of the culture (ICH Q5A Document)". , - ", . , . , , . 2) "Bankable cells" , : "Cells after in vitro expansion are stored by mean of cryopreservation and under such conditions, their biological characteristics are not significantly altered. Such cells are subject to full characterisation, quality control testing and storage for subsequent retrieval for manipulation, administration to the patients". , ", "?... - . |
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