FDA 发布 Q5B 最终指南，涉及重组 DNA 蛋白生产用细胞表达构建体的分析
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
FDA 发布 Q5B 最终指南，说明重组 DNA 蛋白产品生产中所用表达构建体的表征，涵盖真核和原核细胞。文件列出评估表达构建体结构时认为有价值的信息类型，并说明不覆盖 r-DNA 衍生药品的全部质量方面，档案编号为 FDA-1995-D-0245。
GUIDANCE DOCUMENT
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
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.
来源：FDA Pharmaceutical Quality Documents · fda.gov