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GUIDANCE DOCUMENT

Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products February 1996

Final
Docket Number:
FDA-1995-D-0245
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document presents guidance regarding the characterization of the expression construct for the production of recombinant DNA (r-DNA) protein products in eukaryotic and prokaryotic cells. The document is intended to describe the types of information that are considered valuable in assessing the structure of the expression construct used to produce r-DNA derived proteins. The document is not intended to cover the entire quality aspect of r-DNA derived medicinal products.


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All written comments should be identified with this document's docket number: FDA-1995-D-0245.