Quality by Design risk assessments supporting approved antibody products

被引：8

作者：

Kelley, Brian ^{[1
]}

机构：

[1] Genentech Inc, San Francisco, CA USA

来源：

MABS | 2016年 / 8卷 / 08期

关键词：

Control strategy; critical quality attributes; design space; product licensure; Quality by Design; risk assessment; MONOCLONAL-ANTIBODIES; PRINCIPLES; MANAGEMENT;

D O I：

10.1080/19420862.2016.1232218

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

引用

页码：1435 / 1436

页数：2

共 19 条

[1] Determination of critical quality attributes for monoclonal antibodies using quality by design principles
Alt, Nadja
Zhang, Taylor Y.
Motchnik, Paul
Taticek, Ron
Quarmby, Valerie
Schlothauer, Tilman
Beck, Hermann
Emrich, Thomas
Harris, Reed J.
[J]. BIOLOGICALS, 2016, 44 (05) : 291 - 305
[2] [Anonymous], 2009, QUALITY DESIGN BIOPH
[3] [Anonymous], 2009, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH harmonized tripartite guideline
[4] [Anonymous], 2005, ICH HARM TRIP GUID Q
[5] [Anonymous], 2008, ICH HARM TRIP GUID P
[6] CMC Biotech Working Group Study Guide, 2009, A-Mab: A Case Study in Bioprocess Development
[7] Introduction to the application of QbD principles for the development of monoclonal antibodies
Finkler, Christof
Krummen, Lynne
[J]. BIOLOGICALS, 2016, 44 (05) : 282 - 290
[8] Process characterization and Design Space definition
Hakemeyer, Christian
McKnight, Nathan
St John, Rick
Meier, Steven
Trexler-Schmidt, Melody
Kelley, Brian
Zettl, Frank
Puskeiler, Robert
Kleinjans, Annika
Lim, Fred
Wurth, Christine
[J]. BIOLOGICALS, 2016, 44 (05) : 306 - 318
[9] International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2012, ICH HARM TRIP GUID D
[10] Integration of QbD risk assessment tools and overall risk management
Kelley, Brian
Cromwell, Mary
Jerkins, Joe
[J]. BIOLOGICALS, 2016, 44 (05) : 341 - 351

← 1 2 →