Production of recombinant protein therapeutics in cultivated mammalian cells

Nature Biotechnology

Volumn 22, Issue 11, 2004, Pages 1393-1398

  Wurm, Florian M ^a  

^a EPFL   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ANIMAL CELL CULTURE; BACTERIA; LIVING SYSTEMS STUDIES; PROCESS CONTROL; VOLUMETRIC ANALYSIS; YEAST;

CELL ENGINEERING; CLINICAL APPLICATIONS; PROTEIN FOLDING;

PROTEINS;

ALTEPLASE; BLOOD CLOTTING FACTOR 8; ERYTHROPOIETIN; PLASMINOGEN ACTIVATOR; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT PROTEIN;

ANIMAL CELL; BACTERIUM; CELL CULTURE; CELL LINE; CELL MATURATION; COMPARATIVE STUDY; DNA INTEGRATION; GENE AMPLIFICATION; GENE EXPRESSION; GENE TARGETING; HAMSTER; MAMMAL CELL; NONHUMAN; PLANT; PRIORITY JOURNAL; PRODUCTIVITY; PROTEIN ASSEMBLY; PROTEIN ENGINEERING; PROTEIN EXPRESSION; PROTEIN FOLDING; PROTEIN MODIFICATION; PROTEIN QUALITY; RECOMBINANT GENE; REVIEW; YEAST;

ANIMALS; BIOREACTORS; CELL CULTURE TECHNIQUES; CELLS, CULTURED; GENETIC ENHANCEMENT; HUMANS; MAMMALS; PROTEIN ENGINEERING; RECOMBINANT PROTEINS; TRANSFECTION;

ANIMALIA; BACTERIA (MICROORGANISMS); CRICETINAE; MAMMALIA;

EID: 8344271026     PISSN: 10870156     EISSN: None     Source Type: Journal    
DOI: 10.1038/nbt1026     Document Type: Review

References (49)

1. Robinson, D.K. & Memmert, K.W. Kinetics of recombinant immunoglobulin production by mammalian cells in continuous culture. Biotechnol. Bioeng. 38, 972-976 (1991).
2. Ringold, G., Dieckmann, B. & Lee, F. Co-expression and amplification of dihydrofolate reductase cDNA and the Escherichia coli XGPRT gene in Chinese hamster ovary cells. J. Mol. Appl. Genet. 1, 165-175 (1981).
3. Gopalkrishnan, R.V. et al. Use of the human EF-1alpha promoter for expression can significantly increase success in establishing stable cell lines with consistent expression: a study using the tetracycline-inducible system in human cancer cells. Nucleic Acids Res. 27, 4775-4782 (1999).
4. Le Hir, H., Nott, A., Moore, M.J. How introns influence and enhance eukaryotic gene expression. Trends in Biochem. Sci. 215-220 (2004).
5. Makrides, S.C. Components of vectors for gene transfer and expression in mammalian cells. Protein Expr. Purif. 17, 183-202 (1999).
6. Graham, F.L. & van der Eb, A.J. A new technique for the assay of infectivity of human adenovirus 5 DNA. Virology 52, 456-467 (1973).
7. Norton, P.A. & Pachuk, C.J. Methods for DNA introduction into mammalian cells, in Gene Transfer and Expression in Mammalian Cells, (ed. Makrides, S.C.) 265-277 (Elsevier Science BV, Amsterdam, 2003).
8. Balland, A. et al. Characterisation of two differently processed forms of human recombinant factor IX synthesised in CHO cells transformed with a polycistronic vector. Eur. J. Biochem. 172, 565-572 (1988).
9. Finn, G.K., Kurz, B.W., Cheng, R.Z. & Shmookler, R.J. Homologous plasmid recombination is elevated in immortally transformed cells. Mol. Cell. Biol. 9, 4009-4017 (1989).
10. Perucho, M., Hanahan, D. & Wigler, M. Genetic and physical linkage of exogenous sequences in transformed cells. Cell 22, 309-317 (1980).
11. Richards, E.J. & Elgin, S.C. Epigenetic codes for heterochromatin formation and silencing: rounding up of the usual suspects. Cell 108, 489-500 (2002).
12. Mutskov, V. & Felsenfeld, G. Silencing of transgene transcription precedes methylation of promoter DNA and histone H3 lysine. EMBO J. 23, 138-149 (2004).
13. Girod, P.-A. & Mermod, N. Use of scaffold/matrix-attachment regions for protein production. in Gene Transfer and Expression in Mammalian Cells. (ed. Makrides, S.C.) 359-379 (Elsevier Science BV, Amsterdam, 2003).
14. Antoniou, M. et al. Transgenese encompassing dual-promoter CpG islands from the human TBP and H NRPA2B1 loci are resistant to heterochromatin-mediated silencing. Genomics 82, 269-279 (2003).
15. Kwaks, T.H.J. et al. Identification of anti-repressor elements that confer high and stable protein production in mammalian cells. Nat. Biotechnol. 21, 553-558 (2003).
16. Fernandez, L.A., Winkler, M. & Grosschell, R. Matrix attachment region-dependent function of the immunoglobulin mu enhancer involves histone acetylation at a distance without changes in enhancer occupancy. Mol. Cell. Biol. 21, 196-208 (2001).
17. Zahn-Zabal, M. et al. Development of stable cell lines for production or regulated expression using matrix attachment regions. J. Biotechnol. 87, 29-42 (2001).
18. Gorman, C.M., Howard, B.H. & Reeves, R. Expression of recombinant plasmids in mammalian cells is enhanced by sodium butyrate. Nucleic Acids Res. 11, 7631-7648 (1983).
19. Cuisset, L., Tichonicky, L. & Delpech, M.A. Protein phosphatase is involved in the inhibition of histone diacetylation by sodium butyrate. Biochem. Biophys. Res. Comm. 246, 760-764 (1998).
20. Zheng, H. & Wilson, J.H. Gene targeting in normal and amplified cell lines. Nature 344, 170-173 (1990).
21. Wurm, F.M., Johnson, A., Lie, Y.S., Etcheverry, M.T. & Anderson, K.P. Host cell derived retroviral sequences enhance transfection and expression efficiency in CHO cells. in Animal Cell Technology: Developments, Processes and Products (eds. R.E. Spier, J.B. Griffiths, C. MacDonnald) 35-41 (Butterworth-Heinemann, Oxford, UK, 1992).
22. Bode, J. et al. Architecture and utilization of highly expressed genomic sites. in Gene Transfer and Expression in Mammalian Cells. (ed. Makrides, S.C.) 551-571 (Elsevier Science, BV, Amsterdam, 2002).
23. Wilson, T.J. & Kola, I. The LoxP/CRE system and genome modification. Methods Mol. Biol. 158, 83-94 (2001).
24. Arden, N., Nivtchanyong, T. & Betenbaugh, M.J. Cell Engineering blocks stress and improves biotherapeutic production. Bioprocessing 3, 23-28 (2004).
25. 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 expression of the bcl-2 gene. Biotechnol. Bioeng. 59, 90-98 (1999).
26. Umana, P., Jean-Mairet, J., Moudry, R., Amstutz, H. & Bailey, J.E. Engineered glycoforms of an antineuroblastoma IgG1 with optimized antibody-dependent cellular cytotoxic activity. Nat. Biotechnol. 17, 176-180 (1999).
27. Pallavicini, M.G. et al. Effects of methotrexate on transfected DNA stability in mammalian cells. Mol. Cell. Biol. 10, 401-404 (1990).
28. Gandor, C., Leist, C., Fiechter, A. & Asselbergs, F.A. Amplification and expression of recombinant genes in serum-independent Chinese hamster ovary cells. FEBS Lett. 377, 290-294 (1995).
29. Wurm, F.M., Gwinn, K.A. & Kingston, R.E. Inducible overexpression of the mouse c-myc protein in mammalian cells. Proc. Natl. Acad. Sci. USA 83, 5414-5418 (1986).
30. Zettlmeissl, G., Wirth, M., Hauser, H.J. & Küpper, H.A. Isolation of overproducing recombinant mammalian cells by a fast and simple selection procedure. Gene 73, 419-426 (1988).
31. Bebbington, C.R., et al. High level expression of a recombinant antibody from myeloma cells using a glutamine synthetase gene as an amplifiable selectable marker. Bio/Technology 10, 169-175 (1992).
32. Barnes, L.M., Bentley, C.M. & Dickson, A.J. Advances in animal cell recombinant protein production: GS-NSO expression system. Cytotechnology 32, 109-123 (2000).
33. Barnes, L.M., Bentley, C.M. & Dickson, A.J. Molecular definition of predictive indicators of stable protein expression in recombinant NSO myeloma cells. Biotechnol. Bioeng. 85, 115-121 (2004).
34. Jones, D. et al. High level expression of recombinant IgG in the human cell line PER.C6. Biotechnol. Prog. 19, 163-168 (2003).
35. Mazur, X., Fussenegger, M., Renner, W.A. & Bailey, J.E. Higher productivity of growth-arrested Chinese hamster ovary cells expressing the cyclin-dependent kinase inhibitor p27. Biotechnol. Prog. 14, 705-713 (1998).
36. Gorman, C.M., Howard, B.H. & Reeves, R. Expression of recombinant plasmids in mammalian cells is enhanced by sodium butyrate. Nucleic Acids Res. 11, 7631-7648 (1983).
37. Hsu, T.C. Chromosomal evolution in cell populations. Int. Rev. Cytol. 12, 69-121 (1961).
38. Barnes, L.M., Bentley, C.M. & Dickson, A.J. Characterization of the stability of recombinant protein production in the GS-NSO expression system. Biotechnol. Bioeng. 73, 261-270 (2001).
39. Wurm, F.M., Pallavicini, M.G. & Arathoon, R. Integration and stability of CHO amplicons containing plasmid sequences. Dev. Biol. Stand. 76, 69-82 (1992).
40. Kim, S.J. & Lee, G.M. Cytogenetic analysis 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. 64, 741-749 (1999).
41. Loumaye, E. et al. Recombinant follicle stimulating hormone: development of the first biotechnology product for the treatment of infertility. Hum. Reprod. Update 4, 862-881 (1998).
42. Spier, R. & Kadouri, A. The evolution of processes for the commercial exploitation of anchorage-dependent animal cells. Enzyme Microb. Technol. 21, 2-8 (1997).
43. Bödecker, B.G.D., Newcomb, R., Yuan, P., Braufman, A. & Kelsey, W. Production of recombinant Factor VIII from perfusion cultures: I. Large Scale Fermentation. in Animal Cell Technology, Products of Today, Prospects for Tomorrow, (eds. R.E. Spier, J.B. Griffiths, and W. Berthold) 580-590 (Butterworth-Heinemann, Oxford, UK, 1994).
44. Wurm, F.M. & Bernard, A.R. Large scale transient expression in mammalian cells for recombinant protein production. Curr. Opin. Biotechnol. 10, 156-159 (1999).
45. Sinacore, M.S., Drapeau, D. & Adamson, S.R. Adaptation of mammalian cells to growth in serum-free media. Mol. Biotechnol. 15, 249-257 (2000).
46. Mather, J.P. Laboratory scale up of cell cultures (0.5-50 liters). Methods Cell Biol. 57, 219-227 (1998).
47. De Jesus, M., et al. TubeSpin satellites: a fast track approach for process development with animal cells using shaking technology. Biochem. Eng. J. 17, 217-223 (2004).
48. Weber, W. et al. Gas-inducible transgene expression in mammalian cells, mice and bioreactor. Nat. Biotechnol. 22, 1440-1444 (2004).
49. Kaufmann, H. & Fussenegger, M. Metabolic engineering of mammalian cells for higher protein yield. in Gene Transfer and Expression in Mammalian Cells (ed. Makrides, S.C.) 457-569 (Elsevier Science, BV, Amsterdam, 2003).