Design Space Development for Lyophilization Using DOE and Process Modeling

被引：1

作者：

Sundaram, Jagannathan ^{[1
]}

Shay, Yun-Hua Max

Hsu, Chung C. ^{[1
]}

Sane, Samir U. ^{[1
]}

机构：

[1] Genentech Inc, Proc Res & Dev, San Francisco, CA 94080 USA

来源：

BIOPHARM INTERNATIONAL | 2010年 / 23卷 / 09期

关键词：

PROTEIN FORMULATIONS; QUALITY;

D O I：

暂无

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：

In the Quality by Design framework, there is a significant emphasis on the robust characterization of manufacturing processes and prospectively identifying manufacturing design space that ensures product quality. In this article, we discuss an approach that leverages risk assessments, design of experiments, and mechanistic modeling of unit operations to establish a design space that is relevant for manufacturing. We present an overview of our methodology and its application to lyophilization process characterization for a monoclonal antibody formulation.

引用

页码：26 / +

页数：9

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