Defining process design space for monoclonal antibody cell culture

Biotechnology and Bioengineering

Volumn 106, Issue 6, 2010, Pages 894-905

  Abu Absi, Susan Fugett ^a   Yang, LiYing ^a   Thompson, Patrick ^a   Jiang, Canping ^a   Kandula, Sunitha ^a   Schilling, Bernhard ^a   Shukla, Abhinav A ^a  

^a BRISTOL MYERS SQUIBB COMPANY   (United States)

Author keywords

Cell culture; Design space; Monoclonal antibody; Quality by design

Indexed keywords

CELL CULTURE PROCESS; CENTRAL COMPOSITE DESIGNS; DESIGN SPACE; DESIGN SPACES; FAILURE MODES AND EFFECTS ANALYSIS; IN-PROCESS CONTROL; INTEGRATED FASHION; MANUFACTURING PROCESS; OPERATING CONDITION; OPERATIONAL PARAMETERS; OPERATIONAL VARIABLES; PROCESS CHARACTERIZATION; PROCESS PERFORMANCE; PRODUCT QUALITY; QUALITY BY DESIGNS; SHAKE FLASKS; TWO STAGE DESIGNS; UPSTREAM PROCESS;

BIOCONVERSION; BIOREACTORS; DESIGN OF EXPERIMENTS; FAILURE ANALYSIS; MONOCLONAL ANTIBODIES; PROCESS DESIGN; PRODUCTIVITY; QUALITY ASSURANCE; QUALITY CONTROL; SAFETY FACTOR; SURFACE PLASMON RESONANCE;

CELL CULTURE;

MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

ANALYTIC METHOD; ANALYTICAL PARAMETERS; ANIMAL CELL; ANIMAL CELL CULTURE; ANTIBODY ENGINEERING; ARTICLE; BIOREACTOR; CHO CELL; CLEARANCE; FAILURE MODES AND EFFECTS ANALYSIS; FEMALE; GLYCOSYLATION; GOOD MANUFACTURING PRACTICE; NONHUMAN; PHARMACEUTICAL ENGINEERING; PROCESS DESIGN; PROCESS OPTIMIZATION; PRODUCT DEVELOPMENT; PRODUCTIVITY; PURIFICATION; ANIMAL; BIOSYNTHESIS; BIOTECHNOLOGY; CHO CELL LINE; CRICETULUS; CULTURE TECHNIQUE; DRUG INDUSTRY; HAMSTER; PROCEDURES;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOREACTORS; BIOTECHNOLOGY; CELL CULTURE TECHNIQUES; CHO CELLS; CRICETINAE; CRICETULUS; DRUG INDUSTRY; RECOMBINANT PROTEINS;

EID: 77955681856     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22764     Document Type: Article

References (22)

1. Ahn WS, Jeon JJ, Jeong YR, Lee SJ, Yoon SK. 2008. Effect of culture temperature on erythropoietin production and glycosylation in a perfusion culture of recombinant CHO cells. Biotechnol Bioeng 101(6):1234-1244.
2. Andersen DC, Bridges T, Gawlitzek M, Hoy C. 2000. Multiple cell culture factors can affect the glycosylation of Asn-184 in CHO-produced tissue-type plasminogen activator. Biotechnol Bioeng 70(1):25-31.
3. US Food and Drug Administration. 2004. Pharmaceutical cGMPs for the 21st century; a risk based approach.
4. US Food and Drug Administration. 2006. Guidance for industry; Q8 pharmaceutical development.
5. US Food and Drug Administration. 2009. Guidance for industry; Q8 pharmaceutical development (Revision 1).
6. Gawlitzek M, Estacio M, Furch T, Kiss R. 2009. Identification of cell culture conditions to control N-glycosylation site-occupancy of recombinant glycoproteins expressed in CHO cells. Biotechnol Bioeng 103(6):1164-1175.
7. Harms J, Wang X, Kim T, Yang X, Rathore AS. 2008. Defining process design space for biotech products: Case study of Pichia pastoris fermentation. Biotechnol Prog 24(3):655-662.
8. Jefferis R. 2005. Glycosylation of recombinant antibody therapeutics. Biotechnol Prog 21(1):11-16.
9. Kelley B, Jennings P, Wright R, Briasco C. 1997. Demonstrating process robustness for chromatographic purification of a recombinant protein. Biopharm Int 10(10):36-47.
10. Kelley B, Shi L, Bonam D, Hubbard B. 1998. Robustness testing of a chromatographyic purification step used in recombinant Factor IX manufacture. In: Kelly B, Ramlemeier A, editors. Validation of biopharmaceutical manufacturing processes. Washington, DC: American Chemical Society. p 93-113.
11. Kozlowski S, Swann P. 2006. Current and future issues in the manufacturing and development of monoclonal antibodies. Adv Drug Deliv Rev 58(5-6):707-722.
12. Li F, Hashimura Y, Pendleton R, Harms J, Collins E, Lee B. 2006. A systematic approach for scale-down model development and characterization of commercial cell culture processes. Biotechnol Prog 22(3):696-703.
13. Lipsanen T, Antikainen O, Raikkonen H, Airaksinen S, Yliruusi J. 2007. Novel description of a design space for fluidised bed granulation. Int J Pharm 345(1-2):101-107.
14. Nail S, Searles J. 2008. Elements of quality by design in development and scale-up of freeze parenterals. Biopharm Int 21(1):44-52.
15. Rathore AS, Winkle H. 2009. Quality by design for biopharmaceuticals. Nat Biotechnol 27(1):26-34.
16. Rathore A, Branning R, Cecchini D. 2007. Design space for biotech products. Biopharm Int 20(5):36-40.
17. Rathore A, Saleki-Gerhardt A, Montgomery S, Tyler S. 2008. Quality by design: Industrial case studies on defining and implementing design space for pharmaceutical processes - Part 1. Biopharm Int 21(12): 37-47.
18. Rathore A, Saleki-Gerhardt A, Montgomery S, Tyler S. 2009. Quality by design: Industrial case studies on defining and implementing design space for pharmaceutical processes - Part 2. Biopharm Int 22(1):40-44.
19. Seely R, Haury J. 2005. Application of FMEA to biotechnology manufacturing processes. In: Rathore A, Sofer G, editors. Porcess validation in manufacturing of biopharmaceuticals. Boca Raton, FL: Taylor and Francis. p 31-68.
20. Seely J, Seely R. 2003. A rational step-wise approach to process characterization. Biopharm Int 16(8):24-35.
21. Shukla AA, Hinckley P. 2008. Host cell protein clearance during protein A chromatography: Development of an improved column wash step. Biotechnol Prog 24(5):1115-1121.
22. Shukla AA, Sorge L, Boldman J, Waugh S. 2001. Process characterization for metal-affinity chromatography of an Fc fusion protein: A design-of-experiments approach. Biotechnol Appl Biochem 34 (Pt 2):71-80.