U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
  1. Search for FDA Guidance Documents

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

Download the Final Guidance Document Read the Federal Register Notice
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.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

Back to Top