A comprehensive strategy to evaluate single-use bioreactors for pilot-scale cell culture production

American Pharmaceutical Review

Volumn 15, Issue 3, 2012, Pages

  Krishnan, Rajesh ^a   Chen, Hao ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMMONIA; BUFFER; MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN; STAINLESS STEEL;

ANTIBODY TITER; BIOREACTOR; BIOTECHNOLOGY; CELL COUNT; CELL CULTURE; CELL GROWTH; CHROMATOGRAPHY; COMMERCIAL PHENOMENA; COST; CULTURE MEDIUM; DANGEROUS GOODS; DISPOSABLE EQUIPMENT; EVALUATION; FOAMING; GAS DIFFUSION; MEDICAL INSTRUMENTATION; METABOLITE; PROCEDURES; PROCESS CONTROL; QUALITY CONTROL; RELIABILITY; REVIEW; SAMPLING; SOLUTION AND SOLUBILITY; STORAGE; TEMPERATURE; TUBE; WASTE MANAGEMENT;

EID: 84861134190     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (20)

1. Zheng R: The game changer: transforming the biopharmaceutical landscape through single-use technologies. BioProcess International 2010:S4-S9.
2. Downey W, Nicely H: Single-use disposables technologies in biopharmaceutical contract manufacturing. American Pharmaceutical Review 2011, 14(5).
3. Potyrailo RA, Wortley T, Surman C, Monk D, Morris WG, Vincent M, Diana R, Pizzi V, Carter J, Gach G et al: Passive multivariable temperature and conductivity RFID sensors for single-use biopharmaceutical manufacturing components. Biotechnology Progress 2011, 27(3):875-884.
4. Whitford WG: Single-use systems as principal components in bioproduction. BioProcess International 2010:34-42.
5. Rader R, Langer E: Upstream single-use bioprocessing systems - future market trends and growth assessment. BioProcess International 2012, 10(2):5.
6. Rao G, Moreira A, Brorson K: Disposable bioprocessing: The future has arrived. Biotechnology and Bioengineering 2009, 102(2):348-356.
7. Amanullah A, Otero JM, Mikola M, Hsu A, Zhang J, Aunins J, Schreyer HB, Hope JA, Russo AP: Novel microbioreactor high throughput technology for cell culture process development: Reproducibility and scalability assessment of fed-batch CHO cultures. Biotechnology and Bioengineering 2010, 106(1):57-67.
8. Eibl R, Eibl D, Kasper C, van Griensven M, Pörtner R: Application of Disposable Bag Bioreactors in Tissue Engineering and for the Production of Therapeutic Agents Bioreactor Systems for Tissue Engineering. In., vol. 112: Springer Berlin / Heidelberg; 2009: 183-207.
9. Öncül AA, Kalmbach A, Genzel Y, Reichl U, Thévenin D: Characterization of flow conditions in 2 L and 20 L wave bioreactors® using computational fluid dynamics. Biotechnology Progress 2010, 26(1):101-110.
10. Eibl R, Kaiser S, Lombriser R, Eibl D: Disposable bioreactors: the current state-of-the-art and recommended applications in biotechnology. Applied Microbiology and Biotechnology 2010, 86(1):41-49.
11. Carson KL: Flexibility-the guiding principle for antibody manufacturing. Nature Biotechnology 2005, 23:1054-1058.
12. Chon JH, Zarbis-Papastoitsis G: Advances in the production and downstream processing of antibodies. New Biotechnology 2005, 28(5):458-463.
13. Johnson M, Lanthier S, Massie B, Lefebvre G, Kamen AA: Use of the Centritech Lab Centrifuge for Perfusion Culture of Hybridoma Cells in Protein-Free Medium. Biotechnology Progress 1996, 12(6):855-864. (Pubitemid 27015841)
14. Jones SD, Ransohoff TC: Single-use products for bioproduciton: available options for cell culutre and downstream processing. American Pharmaceutical Review 2011, 14(4).
15. Rolf H: Expanded-bed adsorption in industrial bioprocessing: Recent developments. Trends in Biotechnology 1997, 15(6):230-235.
16. Lim JAC, Sinclair A, Kim DS, Gottschalk U: Economic benefits of single-use membrane chromatography in polishing. BioProcess International 2007:46-56.
17. Paul Smelko J, Rae Wiltberger K, Francis Hickman E, Janey Morris B, James Blackburn T, Ryll T: Performance of high intensity fed-batch mammalian cell cultures in disposable bioreactor systems. Biotechnology Progress 2011, 27(5):1358-1364.
18. Diekmann S, Durr C, Herrmann A, Lindner I, Jozic D: Single use bioreactors for the clinical production of monoclonal antibodies - a study to analyze the performance of a CHO cell line and the quality of the produced monoclonal antibody. In: BMC Proceedings. vol. 5; 2011: P103.
19. Mullan B, Huntington K, Collins A, Murphy M: Transfer, Implementation and Late Stage Development of an End-To-End Single-Use Process for Monoclonal Antibody Manufacture. American Pharmaceutical Review 2011, 14 (1).
20. Kapp T, Boehm J, Chase J, Craig J, Davis K, Gupta V, Stover J, Wilkowski S, Montgomery SA, Ott K: Road map to implementation of single-use systems. BioProcess International 2010, 8:S10-S19.