Application of quality by design principles to the development and technology transfer of a major process improvement for the manufacture of a recombinant protein

Biotechnology Progress

Volumn 27, Issue 6, 2011, Pages 1718-1729

  Looby, Mairead ^a   Ibarra, Neysi ^a   Pierce, James J ^a   Buckley, Kevin ^a   O'Donovan, Eimear ^a   Heenan, Mary ^a   Moran, Enda ^a   Farid, Suzanne S ^b   Baganz, Frank ^b  

^a PFIZER INC   (United States)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

CHO; Process characterization; Process validation; QbD; Virus inactivation

Indexed keywords

CHO; PROCESS CHARACTERIZATION; PROCESS VALIDATION; QBD; VIRUS INACTIVATION;

CELL CULTURE; CHARACTERIZATION; COMPUTER SIMULATION; DESIGN; DESIGN OF EXPERIMENTS; EXPERIMENTS; INDUSTRIAL ENGINEERING; MANUFACTURE; MONTE CARLO METHODS; PARAMETER ESTIMATION; PRODUCTION ENGINEERING; PROTEINS; RISK ASSESSMENT; TECHNOLOGY TRANSFER; VIRUSES;

PROCESS DESIGN;

DRUG; RECOMBINANT PROTEIN;

ANIMAL; ARTICLE; BATCH CELL CULTURE; BIOTECHNOLOGY; CHO CELL; CRICETULUS; EVALUATION; GENETICS; HAMSTER; METABOLISM; METHODOLOGY; QUALITY CONTROL; STANDARD; TECHNOLOGY;

ANIMALS; BATCH CELL CULTURE TECHNIQUES; BIOTECHNOLOGY; CHO CELLS; CRICETINAE; CRICETULUS; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; RECOMBINANT PROTEINS; TECHNOLOGY TRANSFER;

CRICETULUS GRISEUS;

EID: 82955249266     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.672     Document Type: Article

References (40)

1. CMC Biotech Working Group. A-Mab: a case study in Bioprocess Development version 2.1. 2009. .
2. Rathore AS, Winkle H. Quality by design for Biopharmaceuticals. Nat Biotechnol. 2009; 27: 26-34.
3. Garcia T, Cook G, Nosal R. PQLI key topics - criticality, design space, and control Strategy. J Pharm Innov. 2008; 3: 60-68.
4. Nosal R, Schultz T. PQLI Definition of criticality. J Pharm Innov. 2008; 3: 69-78.
5. Lepore J, Spavins J. PQLI Design space. J Pharm Innov. 2008; 3: 79-87.
6. Bolton R, Tyler S. PQLI Engineering controls and automation strategy. J Pharm Innov. 2008; 3: 88-94.
7. Davis B, Lundsberg L, Cook G. 2008. PQLI control strategy model and concepts. J Pharm Innov. 2008; 3: 95-104.
8. Del Val Jimenez I, Kontoravdi C, Nagy JM. Towards the implementation of quality by design to the production of therapeutic monoclonal antibodies with desired glycosylation patterns. Biotechnol Prog. 2010; 26: 1505-1527.
9. Abu-Absi SF, Yang LY, Thompson P, Jiang C, Kandula S, Schilling B, Shukla AA, Defining process design space for monoclonal antibody cell culture. Biotechnol Bioeng. 2010; 106: 894-905.
10. Harms J, Wang X, Kim T, Yang X. Rathore AS. Defining process design space for biotech products: case study of Pichia pastoris fermentation. Biotechnol Prog. 2008; 24: 655-662.
11. Jiang C, Flansburg L, Ghose S, Jorjorian P, Shukla AA. Defining process design space for a hydrophobic interaction chromatography (HIC) purification step: application of quality by design (QbD) principles. Biotechnol. Bioeng. 2010; 107: 985-997.
12. Rathore AS, PDFMhatre R, editors. Quality by Design for Biopharmaceuticals: Principles and Case Studies. Hoboken, NJ: Wiley; 2008.
13. ICH. Harmonised tripartite guideline. Pharmaceutical development Q8(R2). 2009. .
14. ICH. Harmonised tripartite guideline. Quality Risk Management. Q9 2006. .
15. ICH. Harmonised tripartite guideline. Pharmaceutical Quality System Q10, 2008. .
16. McDermott RE, Mikulak RJ, Beauregard MR, editors. The Basics of FMEA. New York: Productivity Press; 1996.
17. Seely RJ, Haury J. Applications of FMEA to biotechnology manufacturing processes. In: Rathore AS, Sofer G, editors. Process Validation in Manufacturing of Biopharmaceuticals. Boca Raton, FL: Taylor & Francis; 2005: 31-68.
18. Kelley B. Establishing process robustness using designed experiments In: Sofer G, Zabriskie D, editors. Pharmaceutical Process Validation. New York: Marcel Dekker Press; 1999: 29-60.
19. Moran EB, McGowan ST, McGuire JM, Frankland JE, Oyebade IA, Waller W, Archer LC, Morris LO, Pandya J, Nathan SR, Smith L, Cadette ML, Michalowski JT. A systematic approach to the validation of process control parameters for monoclonal antibody production in fed-batch culture of a murine myeloma. Biotechnol Bioeng. 2000; 69: 242-255.
20. Mandenius CF, Brundin A. Bioprocess optimisation using design of experiments methodology. Biotechnol Prog. 2008; 24: 1191-1203.
21. ICH. Harmonised tripartite guideline. Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5A. 1999. .
22. Brorson K. Krejci S, Lee K. Hamilton E, Stein K, Xu Y. Bracketed generic inactivation of rodent retroviruses by low pH treatment for monoclonal antibodies and recombinant proteins. Biotechnol Bioeng. 2003; 82: 321-329.
23. Hammersley JM, Handscomb DC. Monte Carlo Methods. New York: Wiley; 1964.
24. Wang X, Germansderfer A, Harms J, Rathore AS. Using statistical analysis for setting process validation acceptance criteria for Biotech products. Biotechnol Prog. 2007; 23: 55-60.
25. Betts JI, Doig SD, Baganz F. Characterization and application of a miniature 10 mL stirred-tank bioreactor, showing scale-down equivalence with a conventional 7 L reactor. Biotechnol Prog. 2006; 22: 681-688.
26. Godavarti R, Petrone J, Robinson J, Wright R, Kelley BD, Scale-down models for purification processes: approaches and applications. In: Rathore AS, Sofer G, editors. Process Validation in Manufacturing of Biopharmaceuticals. Boca Raton, FL: Taylor & Francis; 2005; 69-142.
27. Hutchinson N, Bingham N, Murrell N, Farid S, Hoare M. Shear stress analysis of mammalian cell suspensions for prediction of industrial centrifugation and its verification. Biotechnol Bioeng. 2006; 95: 483-491.
28. Li F, Hashimura Y, Pendleton R, Harms J, Collins E, Lee B. A systematic approach for scale-down model development and characterization of commercial cell culture processes. Biotechnol Prog. 2006; 22: 696-703.
29. Nienow AW. Reactor engineering in large scale animal cell culture. Cytotechnology. 2006; 50: 9-33.
30. Titchener-Hooker NJ, Dunnill P, Hoare M. Micro biochemical engineering to accelerate the design of industrial-scale downstream processes for biopharmaceutical proteins. Biotechnol Bioeng. 2008; 100: 473-487.
31. PDA. Process validation of protein manufacturing technical report no 42. PDA J Pharm Sci Technol. 2005; 59: 1-28.
32. Seely RJ, Munyakazi L, Haury J. Statistical tools for setting in-process acceptance criteria. Dev Biol (Basel). 2003; 113: 17-25.
33. Beatrice MG. Biotechnology facility design and process validation. In: Rehm HJ, Reed G, editors. Biotechnology: Bioprocessing, Vol. 3, 2nd ed. Weinheim, Germany: Wiley-VCH Verlag GmbH; 2008: 739-767.
34. Fetterolf DM. Developing a sound process validation strategy. Bio Pharm Int. 2007; 20: 38-47.
35. Haider SI. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance. New York: Saint Lucie Press; 2002.
36. ICH. Harmonised tripartite guideline. Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredient Q7. 2000. .
37. Food and Drug Administration. Guideline on General Principles of Process Validation. 1987. .
38. Food and Drug Administration. Guidance for industry: Process Validation General Principles and Practices, Revision 1. 2011. .
39. EMEA. Annex 15 Qualification and validation. 2001. .
40. 2. Biotechnol Prog. 1997; 13: 311-317.