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

This 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.

Keywords: Expression vector, expression construct, recombinant DNA, rDNA, recombinant proteins, continuous cell line, genomic and phenotypic stability

Current effective version

ICH: Q 5 B: Analysis of the expression construct in cell lines used for production of r-DNA derived protein products - Step 5

Adopted Reference Number: CPMP/ICH/139/95 Legal effective date: 01/07/1996

Superseded document

Production and quality control of medicinal products derived by recombinant dna technology

Adopted Reference Number: 3ab1aen Legal effective date: 01/07/1995