Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Short Title:	Q5B
Internet:	http://private.ich.org/LOB/media/MEDIA426.pdf
Origin/Publisher:
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.
Document Type:	ICH Guideline