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

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 81, Issue 2, 2012, Pages 426-437

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

^a MERCK SERONO S A   (Switzerland)

Author keywords

Cell culture process; Characterization; Design of Experiments (DoE); Design space; Fc Fusion protein; Quality by Design (QbD)

Indexed keywords

DISSOLVED OXYGEN; HYBRID PROTEIN;

ARTICLE; BIOLOGICAL MODEL; BIOREACTOR; CELL CULTURE; CELL DENSITY; CELL EXPANSION; CELL GROWTH; CELL LINE; CELL METABOLISM; DRUG SAFETY; IMMUNOGENICITY; PH; RISK ASSESSMENT;

ANIMALS; BIOREACTORS; CELL CULTURE TECHNIQUES; CELLS, CULTURED; CHO CELLS; CRICETINAE; HYDROGEN-ION CONCENTRATION; IMMUNOGLOBULIN FC FRAGMENTS; OXYGEN; QUALITY CONTROL; RECOMBINANT FUSION PROTEINS; RISK ASSESSMENT;

EID: 84861633234     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2012.02.018     Document Type: Article

References (22)

1. International Conference of Harmonisation, ICH Harmonized Tripartite Guideline, Pharmaceutical Development Q8 (R2), 2009.
2. A.S. Rathore Roadmap for implementation of quality by design (QbD) for biotechnology products Trends Biotechnol. 27 2009 546 553
3. A.S. Rathore, and H. Winkle Quality by Design for biopharmaceuticals Nat. Biotechnol. 27 2009 26 34
4. International Conference of Harmonization, ICH Guidance for Industry, Q9 Quality Risk Management, 2006.
5. S. Kozlowski, and P. Swann Considerations for biotechnology product quality by design A.S. Rathore, R. Mhatre, Quality by Design for Biopharmaceuticals - Principles and Case Studies 2009 Wiley Hoboken, NJ 9 30
6. M.A. Schenerman, J.A. Milton, C.N. Olivier, K. Ram, and G.F. Wasserman Using a risk assessment process to determine criticality of product quality attributes A.S. Rathore, R. Mhatre, Quality by Design for Biopharmaceuticals - Principles and Case Studies 2009 Wiley Hoboken, NJ 53 84
7. F. Li, Y. Hashimura, R. Pendleton, J. Harms, E. Collins, and B. Lee A systematic approach for scale-down model development and characterization of commercial cell culture processes Biotechnol. Prog. 22 2006 696 703
8. A.H. Mollah Application of failure mode and effects analysis (FMEA) for process risk assessment BioProcess Int. 2005 12 20
9. R. Seely, and J. Haury Applications of failure modes and effects Analysis to biotechnology manufacturing processes A.S. Rathore, G. Sofer, Process Validation in Manufacturing of Biopharmaceuticals 2005 Taylor and Francis Boca Raton, FL 31 68
10. G.E.P. Box, and N.R. Draper Empirical Model-Building and Response Surfaces 1987 Wiley New York
11. R.H. Myers, and D. C Montgomary Response Surface Methodology (Process and Product Optimisation using Designed Experiments) 1995 Wiley New York
12. J. Huang, G. Kaul, C. Cai, R. Chatlapalli, P. Hernandez-Abad, K. Gosh, and A. Nagi Quality by design case study: an integrated multivariate approach to drug product and process development Int. J. Pharm. 382 2009 23 32
13. S. Gupta, S.R. Indelicato, V. Jethwa, T. Kawabata, M. Kelly, A.R. Mire-Sluis, S.M. Richards, B. Rup, E. Shores, S.J. Swanson, and E.W. Wakshull Recommendations for the design, optimization and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics J. Immunol. Methods 321 2007 1 18
14. J. Harms, X. Wang, T.K.X. Yang, and A.S. Rathore Defining process design space for biotech products: case study of Pichia pastoris fermentation Biotechnol. Prog. 24 2008 655 662
15. P. Van Hoek, J. Harms, X. Wang, and A.S. Rathore Case study on definition of process design space for a microbial fermentation step A.S. Rathore, R. Mhatre, Quality by Design for Biopharmaceuticals - Principles and Case Studies 2009 Wiley Hoboken, NJ 85 109
16. L.X. Yu Pharmaceutical Quality by Design: product and process development, understanding, and control Pharm. Res. 25 2008 781 791
17. S.F. Abu-Absi, L.Y. Yang, P. Thompson, C. Jiang, S. Kandula, B. Schilling, and A.A. Shukla Defining process design space for monoclonal antibody cell culture Biotechnol. Bioeng. 106 2010 894 905
18. B. Horvath, M. Mun, and M.W. Laird Characterization of a monoclonal antibody cell culture production process using a quality by design approach Mol. Biotechnol. 45 2010 203 206
19. A.S. Rathore, A. Saliki-Gerhardt, S. Montgomery, and S. Tyler Quality by design: industrial case studies on defining and implementing design space for pharmaceutical processes - Part 1 Biopharm. Int. 21 2008 37 47
20. D.J. Cecchini Applications of design space for biopharmaceutical purification processes A.S. Rathore, R. Mhatre, Quality by Design for Biopharmaceuticals - Principles and Case Studies 2009 Wiley Hoboken, NJ 127 142
21. C. Jiang, L. Flansburg, S. Ghose, P. Jorjorian, and A.A. Shukla Defining process design space for a hydrophobic interaction chromatography (HIC) purification step: application of quality by design (QbD) principles Biotechnol. Bioeng. 107 2010 985 997
22. J.L. Vesper Failure mode, effects and criticality analysis (FMECA) J.L. Vesper, Risk Assessment and Risk Management in the Pharmaceutical Industry, Clear and Simple 2006 Davis Healthcare International Publishing, LLC River Grove, IL 163 183