Development of a scale down cell culture model using multivariate analysis as a qualification tool

Author:

Tsang Valerie Liu1,Wang Angela X.1,Yusuf-Makagiansar Helena1,Ryll Thomas1

Affiliation:

1. Cell Culture Development; Biogen Idec, Inc.; 5000 Davis Drive; Research Triangle Park; NC 27709

Publisher

Wiley

Subject

Biotechnology

Reference34 articles.

1. FDA, Guidance for Industry PAT-a framework for innovative pharmaceutical development, manufacturing, and quality assurance 2004

2. Quality by design for biopharmaceuticals;Rathore;Nat Biotechnol,2009

3. The process analytical technology initiative and multivariate process analysis, monitoring and control;Kourti;Anal Bioanal Chem,2006

4. CMC_Biotech_Working_Group. A-Mab: a case study in bioprocess development http://www.casss.org/associations/9165/files/A-Mab_Case_Study_Version_2-1.pdf 2009

5. Equipment design considerations for large scale cell culture;Marks;Cytotechnology,2003

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