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Q 5 B Quality of Biotechnological Products: Analysis of ...

European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged July 1996 CPMP/ICH/139/95 ICH Topic Q 5 B Quality of Biotechnological Products: Analysis of the expression Construct in Cell Lines Used for Production of r-DNA Derived Protein Products Step 5 NOTE FOR GUIDANCE ON Quality OF BIOTECHNOLO-GICAL PRODUCTS.

harvest, and product purification should be identical except for the scale of production. Relevant Genotypic and Phenotypic Markers Those markers permitting the identification of the strain of the cell line which should include the expression of the recombinant protein or presence of the expression construct. Working Cell Bank (WCB)

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