Application of Quality by Design to the characterization of the cell culture process of an Fc-Fusion protein-Reference-Cited by-同舟云学术

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Application of Quality by Design to the characterization of the cell culture process of an Fc-Fusion protein

Published:2012-06 Issue:2 Volume:81 Page:426-437
ISSN:0939-6411
Container-title:European Journal of Pharmaceutics and Biopharmaceutics
language:en
Short-container-title:European Journal of Pharmaceutics and Biopharmaceutics

Author:

Rouiller Yolande,Solacroup Thomas,Deparis Véronique,Barbafieri Marco,Gleixner Ralf,Broly Hervé,Eon-Duval Alex

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference22 articles.

1. International Conference of Harmonisation, ICH Harmonized Tripartite Guideline, Pharmaceutical Development Q8 (R2), 2009.

2. Roadmap for implementation of quality by design (QbD) for biotechnology products;Rathore;Trends Biotechnol.,2009

3. Quality by Design for biopharmaceuticals;Rathore;Nat. Biotechnol.,2009

4. International Conference of Harmonization, ICH Guidance for Industry, Q9 Quality Risk Management, 2006.

5. Considerations for biotechnology product quality by design;Kozlowski,2009

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