Development and Characterization of a Cell Culture Manufacturing Process Using Quality by Design (QbD) Principles

被引：5

作者：

Marasco, Daniel M. ^{[1
]}

Gao, Jinxin ^{[1
]}

Griffiths, Kristi ^{[1
]}

Froggatt, Christopher ^{[1
]}

Wang, Tongtong ^{[1
]}

Wei, Gan ^{[1
]}

机构：

[1] Eli Lilly & Co, Lilly Res Labs, Bioprod Res & Dev, Indianapolis, IN 46285 USA

来源：

MAMMALIAN CELL CULTURES FOR BIOLOGICS MANUFACTURING | 2014年 / 139卷

关键词：

Cell culture process characterization; Cell culture process development; Cell culture process scale-up; Control strategy; Critical quality attribute; Design space; Quality by design; Risk assessment;

D O I：

10.1007/10_2013_217

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

The principles of quality by design (QbD) have been applied in cell culture manufacturing process development and characterization in the biotech industry. Here we share our approach and practice in developing and characterizing a cell culture manufacturing process using QbD principles for establishing a process control strategy. Process development and characterization start with critical quality attribute identification, followed by process parameter and incoming raw material risk assessment, design of experiment, and process parameter classification, and conclude with a design space construction. Finally, a rational process control strategy is established and documented.

引用

页码：93 / 121

页数：29

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