Guideline

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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://www.fda.gov/cder/guidance/ichq5b.pdf
Origin/Publisher:	Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/cder/guidance/index.htm
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:	FDA Guideline for Industry