Strategy for selecting disposable bags for cell culture media applications based on a root-cause investigation

Biotechnology Progress

Volumn 29, Issue 6, 2013, Pages 1535-1549

  Wood, Joseph ^a   Mahajan, Ekta ^a   Shiratori, Masaru ^a  

^a GENENTECH INC   (United States)

Author keywords

Cell culture; Chinese hamster ovary; Disposables; Disposables use test

Indexed keywords

BIOTECH INDUSTRY; CELL CULTURE MEDIA; CHINESE HAMSTER OVARY; CHINESE HAMSTER OVARY CELLS; CLEANING VALIDATION; CROSS CONTAMINATION; DISPOSABLES; GAMMA IRRADIATION;

BIOTECHNOLOGY;

CELL CULTURE;

CRICETULUS GRISEUS;

ANIMAL; ARTICLE; CELL CULTURE; CHEMISTRY; CHINESE HAMSTER OVARY; CHO CELL LINE; CRICETULUS; CULTURE MEDIUM; CULTURE TECHNIQUE; CYTOLOGY; DISPOSABLES; DISPOSABLES USE TEST; HUMAN; METHODOLOGY;

CELL CULTURE; CHINESE HAMSTER OVARY; DISPOSABLES; DISPOSABLES USE TEST;

ANIMALS; CELL CULTURE TECHNIQUES; CHO CELLS; CRICETULUS; CULTURE MEDIA; HUMANS;

EID: 84890166854     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.1802     Document Type: Article

References (19)

1. Rader RA, Langer ES. Upstream single-use bioprocessing systems. BioProcess Int. 2012;10:12-18.
2. The Irradiation and Sterilization Subcommittee of the Bio-Process Systems Alliance. Guide to irradiation and sterilization validation of single-use bioprocess systems. BioProcess Int. 2008:10-22.
3. Green S, Bai S, Cheatham M, Cong R, Yau W. Determination of antioxidants in polyolefins using total dissolution methodology followed by RPLC. J Sep Sci. 2010;33:3455-3462.
4. Boragno L, Stagnaro P, Losio S, Sacchi M, Menichetti S, Viglianisi C, Piergiovanni L, Limbo S. LDPE-based blends and films stabilized with nonreleasing polymeric antioxidants for safer food packaging. J Appl Polym Sci. 2011;124:3912-3920.
5. Wu C, McGinity J. Influence of methylparaben as a solid-state plasticizer on the physicochemical properties of Eudragit RS PO hot-melt extrudates. Eur J Pharm Biopharm. 2003;56:95-100.
6. Sankhe S, Hirt D. Using synchrotron-based FT-IR microspectroscopy to study erucamide migration in 50-micron-thick bilayer linear low-density polyethylene and polyolefin plastomer films. Appl Spectrosc. 2003;57:37-43.
7. Buchalla R, Boess C, Bögl KW. Analysis of volatile radiolysis products in gamma-irradiated LDPE and polypropylene films by thermal desorption-gas chromatography-mass spectrometry. Appl Radiati Isot. 2000;52:251-269.
8. Andersson T, Nielsen T, Wesslén B. Degradation of low density polyethylene during extrusion. III. Volatile compounds in extruded films creating off-flavor. J Appl Polym Sci. 2005;95:847-858.
9. Premnath V, Harris W, Jasty M, Merill E. Gamma sterilization of UHMWPE articular implants: an analysis of the oxidation problem. Biomaterials. 1996;17:1741-1753.
10. Mahajan E, Ray-Chaudhuri T, Vogel J. Standardization of single use components' extractable studies for industry. Pharm Eng. 2012;32:54-56.
11. Urlaub G, Chasin L. Isolation of Chinese hamster cell mutants deficient in dihydrofolate reductase activity. Proc Natl Acad Sci. 1980;77:4216-4220.
12. Puck TS, Cieciura S, Robinson A. Genetics of somatic mammalian cells. J Exp Med. 1958;108:945-955.
13. Kaufman R, Sharp P. Construction of a modular dihydrofolate reductase cDNA gene: analysis of signals utilized for efficient expression. Mol Cell Biol. 1982;2:1304-1319.
14. Eichelberger J, Behymer T, Budde W, Munch J, Shoemaker J. Method 525.2, Determination Of Organic Compounds In Drinking Water By Liquid-Solid Extraction And Capillary Column Gas Chromatography/Mass Spectrometry, Revision 2.0, ″ U.S. Environmental Protection Agency, OH: Cincinnati; 1995.
15. Alford-Stevens A, Eichelberger J, Budde W, Slater R, Munch J, Bellar T. Method 524.2, Measurement of Purgeable Organic Compounds in Water by Capillary Column Gas Chromatography/Mass Spectrometry, U.S. Environmental Protection Agency, OH: Cincinnati; 1992.
16. Shiratori M. Recent experiences with single-use containers used for media storage, media handling and cell culture. In: BioProcess International Conference & Exhibition. CA: Long Beach; 2011.
17. Wood J. Take II-More Findings and Updates on Our Experiences with Disposable Bags for Cell Culture Media Storage, in IBC's 9th International Single-Use Applications for Biopharmaceutical Manufacturing. CA: San Francisco; 2012.
18. Horvath B, Tsang V, Dai X, Frank G. A Generic Growth Test Method for Improving Quality Control of Disposables in Industrial Cell Culture. BioPharm Int. 2013;23:34-41.
19. Skidmore K, Hewitt D, Kao, Y-H. Quantitation and characterization of process impurities and extractables in protein-containing solutions using proton NMR as a general tool. Biotechnol Prog. 2012;28:1526-1533.