ICH Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Title:
ICH Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Origin/Publisher:
Document Type:
ICH Guideline
Content:
This guideline advises on the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins.