Advances in cell culture process development: Tools and techniques for improving cell line development and process optimization

Biotechnology Progress

Volumn 24, Issue 3, 2008, Pages 727-734

  Sharfstein, Susan T ^a  

^a RENSSELAER POLYTECHNIC INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AEROSPACE APPLICATIONS; ARCHITECTURAL DESIGN; CANNING; CHEMICALS; CHEMOTHERAPY; CURVE FITTING; DRUG DELIVERY; DRUG DOSAGE; DRUG THERAPY; ENGINEERS; FOOD PRESERVATION; NUMERICAL METHODS; OPTIMIZATION; PROCESS DESIGN; PROCESS ENGINEERING; PRODUCT DESIGN; PRODUCT DEVELOPMENT; QUALITY CONTROL;

(E ,3E) PROCESS; AMERICAN CHEMICAL SOCIETY (ACS); AMERICAN INSTITUTE OF CHEMICAL ENGINEERS (AICHE); AUTOMATED FLOW; CELL ANALYSIS; CELL LINES; CRITICAL ISSUES; CULTURE SYSTEMS; FOOD AND DRUG ADMINISTRATION (FDA); GLYCOFORM; HIGH-THROUGHPUT (HT); IN-CELL; NOVEL TECHNIQUES; ORAL SESSIONS; PROCESS CONDITIONS; PROCESS DEVELOPMENTS; PROCESS OPTIMIZATION; PROCESS PERFORMANCE; PRODUCT DEMANDS; PRODUCT QUALITIES; PRODUCTION CELLS; SELECTION METHODS; TOOLS AND TECHNIQUES;

CELL CULTURE;

ALGORITHM; BIOLOGICAL MODEL; CELL FUNCTION; CELL LINE; COMPUTER SIMULATION; CONFERENCE PAPER; CULTURE TECHNIQUE; CYTOLOGY; METHODOLOGY; PHYSIOLOGY;

ALGORITHMS; CELL CULTURE TECHNIQUES; CELL LINE; CELL PHYSIOLOGY; COMPUTER SIMULATION; MODELS, BIOLOGICAL;

EID: 45149127403     PISSN: 87567938     EISSN: None     Source Type: Journal    
DOI: 10.1021/bp070471q     Document Type: Conference Paper

References (55)

1. Walsh, G. Biopharmaceutical benchmarks 2006. Nat. Biotechnol. 2006, 24 (7), 769-776.
2. Walsh, G. Approval trends in 2006. Biopharm. Int. 2007, 20 (9), 56.
3. Reichert, J. M.; Wenger, J. B. Development trends for new cancer therapeutics and vaccines. Drug Discovery Today 2007, 13 (1-2), 30-37.
4. Butler, M. Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals. Appl. Microbiol. Biotechnol. 2005, 68 (3), 283-291.
5. Walsh, G.; Jefferis, R. Post-translational modifications in the context of therapeutic proteins. Nat. Biotechnol. 2006, 24 (10), 1241-1252.
6. Sharfstein, S. T.; Nam, J. H. Protein glycosylation: Analysis and characterization. In Bioseparation and Bioprocessing, 2nd ed.; Subramanian, G., Ed.; Wiley-VCH: Weinheim, 2007; pp 631-662.
7. Jenkins, N.; Parekh, R. B.; James, D. C. Getting the glycosylation right: implications for the biotechnology industry. Nat. Biotechnol. 1996, 14 (8), 975-981.
8. Jenkins, N.; Curling, E. M. Glycosylation of recombinant proteins: problems and prospects. Enzyme Microb. Technol. 1994, 16 (5), 354-364.
9. Butler, M. Optimisation of the cellular metabolism of glycosylation for recombinant proteins produced by mammalian cell systems. Cytotechnology 2006, 50 (1-3), 57-76.
10. Process Analytical Technology (PAT) Initiative. http://www.fda.gov/cder/ OPS/PAT.htm.
11. Luu, M.; Kiss, R.; Meier, S. Leveraging process characterization and validation data for continuous process improvement. 234th ACS National Meeting, Boston, MA, 2007.
12. Lu, C.; Gonzalez, C.; Gleason, J.; Gangi, J.; Yang, J.-D. A T-flask based screening platform for evaluating and identifying plant hydrolysates for a fed-batch cell culture process. Cytotechnology 2007, 55 (1), 15-29.
13. Acosta, M.; Sánchez, A.; García, F.; Contreras, A.; Molina, E. Analysis of kinetic, stoichiometry and regulation of glucose and glutamine metabolism in hybridoma batch cultures using logistic equations. Cytotechnology 2007, 54 (3), 189-200.
14. Parampalli, A.; Eskridge, K.; Smith, L.; Meagher, M.; Mowry, M.; Subramanian, A. Developement of serum-free media in CHO-DG44 cells using a central composite statistical design. Cytotechnology 2007, 54 (1), 57-68.
15. Xing, Z.; Li, Z.; Chow, V.; Lee, S. S. Inhibitory threshold values of lactate, ammonia, carbon dioxide, and osmolality in CHO cell culture for a therapeutic protein production. 234th ACS National Meeting, Boston, MA, 2007.
16. Schilling, B. M.; Shukla, A. A.; Lee, S. Metabolic process engineering applied to cell culture production processes. 234th ACS National Meeting, Boston, MA, 2007.
17. Crowell, C. K.; Grampp, G. E.; Rogers, G. N.; Miller, J.; Scheinman, R. I. Amino acid and manganese supplementation modulates the glycosylation state of erythropoietin in a CHO culture system. Biotechnol. Bioeng. 2007, 96 (3), 538-549.
18. Wang, W. Y.; Yi, X. P.; Zhang, Y. X. Gene transcription acceleration: Main cause of hepatitis B surface antigen production improvement by dimethyl sulfoxide in the culture of Chinese hamster ovary cells. Biotechnol. Bioeng. 2007, 97 (3), 526-535.
19. Sauerwald, T. M.; Oyler, G. A.; Betenbaugh, M. J. Study of caspase inhibitors for limiting death in mammalian cell culture. Biotechnol. Bioeng. 2003, 81 (3), 329-340.
20. Vives, J.; Juanola, S.; Cairâo, J. J.; Prats, E.; Cornudella, L.; Gáodia, F. Protective effect of viral homologues of bcl-2 on hybridoma cells under apoptosis-inducing conditions. Biotechnol. Prog. 2003, 19 (1), 84-89.
21. Figueroa, B., Jr.; Sauerwald, T. M.; Oyler, G. A.; Hardwick, J. M.; Betenbaugh, M. J. A comparison of the properties of a Bcl-xL variant to the wild-type anti-apoptosis inhibitor in mammalian cell cultures. Metab. Eng. 2003, 5 (4), 230-245.
22. Jung, D.; Cãotâe, S.; Drouin, M.; Simard, C.; Lemieux, R. Inducible expression of Bcl-XL restricts apoptosis resistance to the antibody secretion phase in hybridoma cultures. Biotechnol. Bioeng. 2002, 79 (2), 180-187.
23. Lee, S. K.; Lee, G. M. Development of apoptosis-resistant dihydrofolate reductase-deficient Chinese hamster ovary cell line. Biotechnol. Bioeng. 2003, 82 (7), 872-876.
24. Simpson, N. H.; Singh, R. P.; Perani, A.; Goldenzon, C.; Al-Rubeai, M. In hybridoma cultures, deprivation of any single amino acid leads to apoptotic death, which is suppressed by the expression of the bcl-2 gene. Biotechnol. Bioeng. 1998, 59 (1), 90-98.
25. Arden, N.; Majors, B. S.; Ahn, S.-H.; Oyler, G. A.; Betenbaugh, M. J. Inhibiting the apoptosis pathway using MDM2 in mammalian cell cultures. 234th ACS National Meeting, Boston, MA, 2007.
26. Arden, N.; Majors, B. S.; Ahn, S. H.; Oyler, G.; Betenbaugh, M. J. Inhibiting the apoptosis pathway using MDM2 in mammalian cell cultures. Biotechnol. Bioeng. 2007, 97 (3), 601-614.
27. Kussie, P. H.; Gorina, S.; Marechal, V.; Elenbaas, B.; Moreau, J.; Levine, A. J.; Pavletich, N. P. Structure of the MDM2 oncoprotein bound to the p53 tumor suppressor transactivation domain. Science 1996, 274 (5289), 948-953.
28. Oliner, J. D.; Pietenpol, J. A.; Thiagalingam, S.; Gvuris, J.; Kinzler, K. W.; Vogelstein, B. Oncoprotein Mdm2 conceals the activation domain of tumor Suppressor-P53. Nature 1993, 362 (6423), 857-860.
29. Ginsberg, D. E2F1 pathways to apoptosis. FEBS Lett. 2002, 529 (1), 122-125.
30. Huang, L.; Kinnucan, E.; Wang, G. L.; Beaudenon, S.; Howley, P. M.; Huibregtse, J. M.; Pavletich, N. P. Structure of an E6AP-UbcH7 complex: Insights into ubiquitination by the E2-E3 enzyme cascade. Science 1999, 286 (5443), 1321-1326.
31. Al-Rubeai, M.; Emery, A. N. Flow Cytometry Applications in Cell Culture; Marcel Dekker: New York, 1996.
32. Abu-Absi, N. R.; Zamamiri, A.; Kacmar, J.; Balogh, S. J.; Srienc, F. Automated flow cytometry for acquisition of time-dependent population data. Cytometry Part A 2003, 51A (2), 87-96.
33. Sitton, G.; Hansgate, A.; Srienc, F. Transient gene expression in CHO cells monitored with automated flow cytometry. Cytotechnology 2006, 52 (1), 13-24.
34. Sitton, G.; Srienc, F. Scale-up of mammalian cell cultures controlled by automated flow cytometry. 234th ACS National Meeting, Boston, MA, 2007.
35. Speciner, L.; Barringer, G.; Perez, J.; Grimaldi, C.; Reineke, R.; Arroyo, A. Implementing an automated reactor sampling system for monitoring cell culture bioreactors. 234th ACS National Meeting, Boston, MA, 2007.
36. Shen, D.; Kiehl, T. R.; Sharfstein, S. T. Proteomic and genomic studies of mammalian cell physiology to optimize production of therapeutic and diagnostic proteins. 234th ACS National Meeting, Boston, MA, 2007.
37. Shen, D.; Sharfstein, S. T. Genome-wide analysis of the transcriptional response of murine hybridomas to osmotic shock. Biotechnol. Bioeng. 2006, 93 (1), 132-145.
38. Dmitrieva, N. I.; Burg, M. B.; Ferraris, J. D. DNA damage and osmotic regulation in the kidney. Am. J. Physiol. Renal Physiol. 2005, 289 (1), F2-F7.
39. Lin, N.; Richardson, G.; Davis, L.; Lacy, K.; Gray, M.; Cresswell, J.; Dennett, A.; Gerber, M.; Caple, M.; Kayser, K. High-producing CHO-GS and NSO-GS cell line generation and characterization using Cell Xpress™ technology. 234th ACS National Meeting, Boston, MA, 2007.
40. Lee, C. J.; Seth, G.; Tsukuda, J.; Hamilton, R. W. Multiplex transcript analysis for identifying high-producing cell lines. 234th ACS National Meeting, Boston, MA, 2007.
41. Borth, N.; Strutzenberger, K.; Kunert, R.; Steinfellner, W.; Katinger, H. Analysis of changes during subclone development and ageing of human antibody-producing heterohybridoma cells by Northern blot and flow cytometry. J. Biotechnol. 1999, 67 (1), 57-66.
42. Fann, C. H.; Guarna, M. M.; Kilburn, D. G.; Piret, J. M. Relationship between recombinant activated protein C secretion rates and mRNA levels in baby hamster kidney cells. Biotechnol. Bioeng. 1999, 63 (4), 464-472.
43. Jiang, Z.; Huang, Y.; Sharfstein, S. T. Regulation of recombinant monoclonal antibody production in Chinese hamster ovary cells: a comparative study of gene copy number, mRNA level, and protein expression. Biotechnol. Prog. 2006, 22 (1), 313-318.
44. Kim, S. J.; Kim, N. S.; Ryu, C. J.; Hong, H. J.; Lee, G. M. Characterization of chimeric antibody producing CHO cells in the course of dihydrofolate reductase-mediated gene amplification and their stability in the absence of selective pressure. Biotechnol. Bioeng. 1998, 58 (1), 73-84.
45. Schlatter, S.; Stansfield, S. H.; Dinnis, D. M.; Racher, A. J.; Birch, J. R.; James, D. C. On the optimal ratio of heavy to light chain genes for efficient recombinant antibody production by CHO cells. Biotechnol. Prog. 2005, 21 (1), 122-133.
46. Jiang, Z.; Sharfstein, S. T. Sodium butyrate stimulates mAb overexpression in CHO cells by improving gene accessibility. 234th ACS National Meeting, Boston, MA, 2007.
47. Jiang, Z.; Sharfstein, S. T. Sodium butyrate stimulates mAb overexpression in CHO cells by improving gene accessibility. Biotechnol. Bioeng. 2008, 100 (1), 189-194.
48. Palermo, D. P.; Degraaf, M. E.; Marotti, K. R.; Rehberg, E.; Post, L. E. Production of analytical quantities of recombinant proteins in Chinese-Hamster Ovary cells using sodium-butyrate to elevate gene-expression. J. Biotechnol. 1991, 19 (1), 35-47.
49. Paterson, T.; Innes, J.; Moore, S. Approaches to maximizing stable expression of alpha(1)-antitrypsin in transformed CHO cells. Appl. Microbiol. Biotechnol. 1994, 40 (5), 691-698.
50. Wang, M. D.; Yang, M.; Huzel, N.; Butler, M. Erythropoietin production from CHO cells grown by continuous culture in a fluidized-bed bioreactor. Biotechnol. Bioeng. 2002, 77 (2), 194-203.
51. Kim, J. S.; Ahn, B. C.; Lim, B. P.; Do Choi, Y.; Jo, E. C. High-level scu-PA production by butyrate-treated serum-free culture of recombinant CHO cell line. Biotechnol. Prog. 2004, 20 (6), 1788-1796.
52. Mimura, Y.; Lund, J.; Church, S.; Dong, S. C.; Li, J.; Goodall, M.; Jefferis, R. Butyrate increases production of human chimeric IgG in CHO-K1 cells whilst maintaining function and glycoform profile. J. Immunol. Methods 2001, 247 (1-2), 205-216.
53. Vidali, G.; Boffa, L. C.; Bradbury, E. M.; Allfrey, V. G. Butyrate suppression of histone deacetylation leads to accumulation of multiacetylated forms of histones H3 and H4 and increased DNase I sensitivity of the associated DNA sequences. Proc. Natl. Acad. Sci. U.S.A. 1978, 75 (5), 2239-2243.
54. Gillmeister, M. P.; Tomiya, N.; Jacobia, S. J.; Lee, Y. C.; Gorfien, S. F.; Betenbaugh, M. J. Improved analytical technique for high throughput analysis of glycoforms. 234th ACS National Meeting, Boston, MA, 2007.
55. Takahashi, N. Three-dimensional mapping of N-linked oligosaccharides using anion-exchange, hydrophobic and hydrophilic interaction modes of high-performance liquid chromatography. J. Chromatogr. A 1996, 720 (1-2), 217-225.