Model-Based Preparative Chromatography Process Development in the QbD Paradigm

Author:

Staby Arne1,Ahuja Satinder2,Rathore Anurag S.3

Affiliation:

1. CMC Project Planning & Management, Novo Nordisk A/S; Bagsvaerd Denmark

2. Ahuja Consulting; Calabash NC USA

3. Department of Chemical Engineering; Indian Institute of Technology; New Delhi India

Publisher

John Wiley & Sons, Inc.

Reference27 articles.

1. ICH Q8(R2) Pharmaceutical Development 2009 International Conference of Harmonization

2. ICH Q9 Quality Risk Management 2005 International Conference of Harmonization

3. ICH Q10 Pharmaceutical Quality System 2008 International Conference of Harmonization

4. ICH Q11 Development and Manufacturing of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) 2012 International Conference of Harmonization

5. M. Degerman E. Hansen L. Sejergaard T.B. Hansen J. Krarup S. Frederiksen S. Kidal A. Staby Model based process development in biopharmaceutical industry-case studies Puerto Vallarta, Mexico 2011

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