Manufacturing Process

rFVII is produced in a baby hamster kidney (BHK) cell line, which was genetically modified by transfection with a plasmid construct containing the human gene for FVII as well as promoter and enhancer regions necessary for transcription. The cDNA for the coding region of human FVII was isolated from a liver gene library and characterized as described previously [22]. For details on transfection of BHK cells with human FVII cDNA, see Berkner, et al. [30].

The transfected cells were cloned and a superior clone selected. This clone was used as a progenitor for establishment of the production cell banks. The cell bank system is two tiered with a master cell bank from which working cell banks can be produced. The cell banks are stored in the vapor phase of liquid nitrogen to ensure stability of the cells during

Man-GlcNAc-GlcNAc-( 145 or322

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