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"I"

in vitro cell age
Guideline or reference source
ICHQ5A Viral safety evaluation of biotech products
ICHQ5B genetic stability
ICHQ5D Derivation and characterisation of cell substrates
Definition
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.
Related Term
in vitro
 

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