ICH Q5B Analysis of the expression construct in cell lines used for production of rDNA-derived protein products

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/139/95
Effective from01/06/1996
KeywordsExpression vector, expression construct, recombinant DNA, rDNA, recombinant proteins, continuous cell line, genomic and phenotypic stability
DescriptionThis document describes the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins.

Document history

First version

Current version

Adopted guidelineIn operation: 01/06/1996–present
Superseded documentAdopted guidelinePublished: 31/12/1994

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