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