Patents in therapeutic recombinant protein production using mammalian cells

Recent Patents on Biotechnology

Volumn 8, Issue 2, 2014, Pages 165-171

  Picanço Castro, Virgínia ^a   de Freitas, Marcela Cristina Corrêa ^a   Bomfim, Aline de Sousa ^a   Russo, Elisa Maria de Sousa ^a  

^a UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

Mammalian expression system; Patents in biopharmaceuticals; Recombinant protein

Indexed keywords

CELL CULTURE; CELLS; MAMMALS; PATENTS AND INVENTIONS;

BIOPHARMACEUTICALS; CELL/B.E; EXPRESSION SYSTEM; HOST CELLS; INDUSTRIAL PRODUCTION; MAMMALIAN CELLS; MAMMALIAN EXPRESSION SYSTEM; PATENT IN BIOPHARMACEUTICAL; RECOMBINANT PROTEIN PRODUCTIONS; STABLE CELL LINES;

RECOMBINANT PROTEINS;

RECOMBINANT PROTEIN; ANTIBODY; BLOOD CLOTTING FACTOR; CULTURE MEDIUM; GROWTH HORMONE;

ARTICLE; CELL CLONE; CELL GROWTH; CULTURE MEDIUM; DOWNSTREAM PROCESSING; ELECTROPORATION; GENE EXPRESSION; GENE SILENCING; HUMAN; MAMMAL CELL; NONHUMAN; PROTEIN EXPRESSION; ANIMAL; BIOSYNTHESIS; CELL LINE; CHEMISTRY; ESCHERICHIA COLI; FUNGUS; GENETICS; METABOLISM; PATENT; PLASMID;

ANIMALS; ANTIBODIES; BLOOD COAGULATION FACTORS; CELL LINE; CULTURE MEDIA; ESCHERICHIA COLI; FUNGI; GROWTH HORMONE; HUMANS; PATENTS AS TOPIC; PLASMIDS; RECOMBINANT PROTEINS;

EID: 84907144174     PISSN: 18722083     EISSN: 22124012     Source Type: Journal    
DOI: 10.2174/1872208309666140904120404     Document Type: Article

References (96)

1. Walsh G. Biopharmaceutical benchmarks 2010. Nat Biotechnol 2010; 28: 917-924.
2. Zhu J. Mammalian cell protein expression for biopharmaceutical production. Biotechnol Adv 2011; doi: 10. 1016/j. biotechadv. 2011. 08. 022.
3. Beck A, Wagner-Rousset E, Bussat MC, et al. Trends in glycosylation, glycoanalysis and glycoengineering of therapeutic antibodies and Fc-fusion proteins. Curr Pharm Biotechnol 2008; 9: 482-501.
4. Havenga MJ, Holterman L, Melis I, Smits S, et al. Serum-free transient protein production system based on adenoviral vector and PER. C6 technology: high yield and preserved bioactivity. Biotechnol Bioeng 2008; 1: 100: 273-83.
5. RepliGen 2011 Annual Report. Available at: http://www. repligen. com/sites/default/files/sitefiles/RepligenARFin al. pdf (Accessed on: February 15, 2013).
6. Wang Z, Troilo PJ, Wang X, et al. Detection of integration of plasmid DNA into host genomic DNA following intramuscular injection and electroporation. Gene Ther 2004; 11: 711-21.
7. Washbourne P, McAllister AK. Techniques for gene transfer into neurons. Curr Opin Neurobiol 2002; 12: 566-73.
8. Potter JE. Inflammation-induced increases in dolichol synthesis and hydroxymethylglutaryl-coenzyme A reductase activity in mouse liver is prevented by a high-cholesterol diet but not by fasting. Biochim Biophys Acta 1984; 796: 393-6.
9. rd Edn. Cold Spring Harbor, NY: Cold Spring Harbor Laboratory 2001.
10. Wurm FM. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat Biotechnol 2004; 22: 1393-8.
11. Wurm F, Bernard A. Large-scale transient expression in mammalian cells for recombinant protein production. Curr Opin Biotechnol 1999; 10: 156-59.
12. Swiech K, Kamen A, Ansorge S et al. Transient transfection of serum-free suspension HEK 293 cell culture for efficient production of human rFVIII. BMC Biotechnol 2011; 11: 1-10.
13. Baldi L, Hacker DL, Adam M, Wurm FM. Recombinant protein production by large-scale transient gene expression in mammalian cells: state of the art and future perspectives. Biotechnol Lett 2007; 29: 677-84.
14. Pham PL, Kamen A, Durocher Y. Large-scale transfection of mammalian cells for the fast production of recombinant protein. Mol Biotechnol 2006; 34: 225-37.
15. Zhu J. Mammalian cell protein expression for biopharmaceutical production. Biotechnol Adv 2012; 30: 1158-70.
16. DePolo NJ, Reed JD, Sheridan PL, et al. VSV-G pseudotyped lentiviral vector particles produced in human cells are inactivated by human serum. Mol Ther 2000; 2: 218-22.
17. Boro Dropulic YNC. Lentiviral vectors and their use. US 20080254008, 2008.
18. Segura MM, Garnier A, Kamen A. Purification and characterization of retrovirus vector particles by rate zonal ultracentrifugation. J Virol Methods 2006; 133: 82-91.
19. Cristiano RJ, Yamashita M. PEI: DNA vector formulations for in vitro and in vivo gene delivery. US 20020151060, 2002.
20. Felgner PL, Ringold GM. Cationic liposome-mediated transfection. Nature 1989; 337: 387-8.
21. Eppstein DA, Felgner PL, Gadek TR, Jones GH, Roman RB, Minder. N-[ω, (ω-1)-dialkyloxy]-and N-[ω, (ω-1)-dialkenyloxy]-alk-1-yl-N, N, N,-tetrasubstituted ammonium lipids and uses therefor. US5366737, 1994.
22. Harris DJERL, Siegel CS, Cheng SH, Eastman SJ, Marshall J. Cationic amphiphiles for intracellular delivery of therapeutic molecules. US5650096, 1997.
23. Remy JS, Sirlin C, Vierling P, Behr JP. Gene transfer with a series of lipophilic DNA-binding molecules. Bioconjug Chem 1994; 5: 647-54.
24. Zabner J, Fasbender AJ, Moninger T, Poellinger KA, Welsh MJ. Cellular and molecular barriers to gene transfer by a cationic lipid. J Biol Chem 1995 Aug 11; 270: 18997-9007.
25. Leventis R, Silvius JR. Interactions of mammalian cells with lipid dispersions containing novel metabolizable cationic amphiphiles. Biochim Biophys Acta 1990; 1023: 124-32.
26. Zhang Y. Lipid particles having asymmetric lipid coating and method of preparing same. US20067005140, 2006.
27. Farhood H, Bottega R, Epand RM, Huang L. Effect of cationic cholesterol derivatives on gene transfer and protein kinase C activity. Biochim Biophys Acta 1992; 1111: 239-46.
28. Leaf HXG, Sorgi FL. Stable lipid-comprising drug delivery complexes and methods for their production. US20117993672, 2011.
29. Hart SL. Methods of transfection. US20040014217, 2004.
30. Joel Vacus TB. Method for preparing compositions for transferring nucleic acids. US6156338, 2000.
31. Wells DJ. Gene therapy progress and prospects: electroporation and other physical methods. Gene Ther 2004; 11: 1363-9.
32. Liu F, Song Y, Liu D. Hydrodynamics-based transfection in animals by systemic administration of plasmid DNA. Gene Ther 1999; 6: 1258-66.
33. Zhang G, Budker V, Wolff JA. High levels of foreign gene expression in hepatocytes after tail vein injections of naked plasmid DNA. Hum Gene Ther 1999; 10: 1735-7.
34. Hagstrom JE, Hegge J, Zhang G, et al. A facile nonviral method for delivering genes and siRNAs to skeletal muscle of mammalian limbs. Mol Ther 2004; 10: 386-98.
35. Zhang X, Dong X, Sawyer GJ, Collins L, Fabre JW. Regional hydrodynamic gene delivery to the rat liver with physiological volumes of DNA solution. J Gene Med 2004; 6: 693-703.
36. Xenariou S, Griesenbach U, Ferrari S, et al. Using magnetic forces to enhance nonviral gene transfer to airway epithelium in vivo. Gene Ther 2006; 13: 1545-52.
37. Holzbach T, Vlaskou D, Neshkova I, et al. Non-viral VEGF gene therapy-magnetofection of acoustically active magnetic lipospheres ("Magnetobubbles") increases tissue-survival in an oversized skin flap model. J Cell Mol Med 2010; 14(3): 587-89.
38. Trimble C, Lin CT, Hung CF et al. Comparison of the CD8+ T cell responses and antitumor effects generated by DNA vaccine administered through gene gun, biojector, and syringe. Vaccine 2003; 21: 4036-42.
39. Alvarez D, Harder G, Fattouh R, et al. Cutaneous antigen priming via gene gun leads to skin-selective Th2 immune-inflammatory responses. J Immunol 2005; 174: 1664-74.
40. Newman CM, Bettinger T. Gene therapy progress and prospects: ultrasound for gene transfer. Gene Ther 2007; 14: 465-75.
41. Suzuki R, Takizawa T, Negishi Y, Utoguchi N, Maruyama K. Effective gene delivery with novel liposomal bubbles and ultrasonic destruction technology. Int J Pharm 2008; 354: 49-55.
42. Zeira E, Manevitch A, Manevitch Z, et al. Femtosecond laser: a new intradermal DNA delivery method for efficient, long-term gene expression and genetic immunization. FASEB J 2007; 21: 3522-33.
43. Tsen SW, Wu CY, Meneshian A, Pai SI, Hung CF, Wu TC. Femtosecond laser treatment enhances DNA transfection efficiency in vivo. J Biomed Sci 2009; 16: 36.
44. Mir LM. Application of electroporation gene therapy: Past, current, and future. Methods Mol Biol 2008; 423: 3-17.
45. McMahon JM, Wells DJ. Electroporation for gene transfer to skeletal muscles: current status. BioDrugs 2004; 18: 155-65.
46. Wells DJ. Electroporation and ultrasound enhanced non-viral gene delivery in vitro and in vivo. Cell Biol Toxicol 2010; 26: 21-8.
47. Gehl J. Electroporation: theory and methods, perspectives for drug delivery, gene therapy and research. Acta Physiol Scand 2003; 177: 437-47.
48. Wang L, Guo M, Cheng J. Methods for improving efficiency of cell electroporation using dielectrophoreses. WO2007079663, 2007.
49. Kiu S, Wang KC. Method for producing stable mammalian cell lines producing high levels of recombinant proteins. WO2007130543, 2007.
50. Hayakawa Y, Hayakawa K. Foreign gene transfer method by electroporation technique. EP2527433, 2012.
51. Walters RE, Walters DC, King AD, Maltais A-K, Wahren B, Haller K, Brane A. Method and apparatus for the delivery of polynucleotide cancer vaccines to mammalian skin. EP2411088, 2012.
52. Jantz D, Smith JJ, Nicholson MG. Methods and products for producing engineered mammalian cell lines with amplified transgenes. WO2012167192, 2012.
53. Gupta SK, Varshney BC. A novel cell line development process to produce recombinant proteins using twin vector expression system. WO2012077128, 2012.
54. Barnes LM, Bentley CM, Dickson AJ. Advances in animal cell recombinant protein production: GS-NS0 expression system. Cytotechnology 2000; 32: 109-23.
55. Wurm FM. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat Biotechnol 2004; 22: 1393-8.
56. Kaufmann H, Florin L, Becker E, Studts JM. Production host cell lines. US20100021911, 2010.
57. McFadd TKC, Yang M. Method for generating stable cell lines expressing high levels of a protein of interest. US20100184090, 2010.
58. Cho MS. Enhanced protein production method. EP0867514, 2011.
59. Cho MS, Chan SY. Factor VIII glycoforms. US20087459525, 2008.
60. Bout A, Hateboer G, Verhulst KC, Uytdehaag AG, Schouten GJ. Recombinant protein production in a human cell. US20097491532, 2009.
61. Cho MS, Chang MS, Lee HJ, Song HC, Kim MS. Method for selecting a high expression recombinant cell line. US20120009682, 2012.
62. Ebner R, Chopra A, Ruben SM. Connective tissue growth factor-3 (CTGF-3). US20110256145, 2011.
63. Rance J, Kalwy S, Young R, Gay R. High-level expression of recombinant antibody in a mammalian host cell. US20090215165, 2009.
64. Friede M, Garcon N. Vaccines. US20110243971, 2011.
65. Kwaks TH, Otte AP. Employing epigenetics to augment the expression of therapeutic proteins in mammalian cells. Trends Biotechnol 2006; 24: 137-42.
66. Wang TY, Yang R, Qin C, Wang L, Yang XJ. Enhanced expression of transgene in CHO cells using matrix attachment region. Cell Biol Int 2008; 32: 1279-83.
67. Lindahl Allen M, Antoniou M. Correlation of DNA methylation with histone modifications across the HNRPA2B1-CBX3 ubiquitously-acting chromatin open element (UCOE). Epigenetics 2007; 2: 227-36.
68. Kennard ML, Goosney DL, Monteith D, et al. The generation of stable, high MAb expressing CHO cell lines based on the artificial chromosome expression (ACE) technology. Biotechnol Bioeng 2009; 15; 104: 540-53.
69. Zhou H, Liu ZG, Sun ZW, Huang Y, Yu WY. Generation of stable cell lines by site-specific integration of transgenes into engineered Chinese hamster ovary strains using an FLP-FRT system. J Biotechnol 2010; 147: 122-129.
70. Kito M, Itami S, Fukano Y, Yamana K, Shibui T. Construction of engineered CHO strains for high-level production of recombinant proteins. Appl Microbiol Biotechnol 2002; 60: 442-8.
71. Durocher Y, Butler M. Expression systems for therapeutic glycoprotein production. Curr Opin Biotech 2009; 20: 700-707.
72. Demain AL, Vaishnav P. Production of recombinant proteins by microbes and higher organisms. Biotechnol Adv 2009; 27: 297-306.
73. Arnold JN, Wormald MR, Sim RB, Rudd PM, Dwek RA. The impact of glycosylation on the biological function and structure of human immunoglobulins. Annu Rev Immunol 2007; 25: 21-50.
74. Higgins E. Carbohydrate analysis throughout the development of a protein therapeutic. Glycoconj J 2009; 27: 211-225.
75. Galili U. Immune response, accommodation, and tolerance to transplantation carbohydrate antigens. Transplantation 2004; 78: 1093-1098.
76. Hokke CH, Bergwerff AA, van Dedem GWK, Kamerling JP, Vliegenthart JFG. Structural analysis of the sialylated N-and Olinked carbohydrate chains of recombinant human erythropoietin expressed in Chinese Hamster Ovary cells. Sialylation patterns and branch of N-acetyllactosamine units. Eur J Biochem 1995: 228: 981-1008.
77. Sandberg H, Stenlund P, Schöder C, Casademunt E, Tiemeyer M. Recombinantly produced human factor VIII and IX. US20110262424, 2011.
78. Fontes AM, Covas DT. Human blood coagulation factor IX recombinant protein, composition, use of a factor IX recombinant protein, use of a composition, method of obtaining human blood coagulation factor IX recombinant protein and use of the factor IX recombinant protein. WO2011011841, 2011.
79. Bolt G, Kristensen C, Boel E, Lundgaard TV. N-glycosylated human growth hormone with prolonged circulatory half-life. US2011/0118183, 2011.
80. Bolt G, Kristensen C, Boel E, Lundgaard TV. N-glycosylated human growth hormone with prolonged circulatory half-life. US20110118183, 2011.
81. Kaufmann H, Florin L, Becker E, Olayioye M, Hausser A, Fugmann T. Protein production. US20090018099, 2009.
82. Chen R, Jeong SS, Feng H. Recombinant production of authentic human proteins using human cell expression systems. WO2011053281, 2011.
83. Bout A, Grimberger JM, Koopman JL. Recombinant fibrinogen. US20110177524, 2011.
84. Vermasvuori R, Koskinen J, Salonen K, et al. Production of recombinant HIV-1 nef protein using different expression host systems: a techno-economical comparison. Biotechnol Prog 2009; 25: 95-102.
85. Improved protein production from mammalian cells. Potential of targeting signals. Available at: http://unitargeting. com/Resources/Paper3. pdf (Accessed on: February 15, 2013).
86. Vermasvuori R, Hurme M. Economic comparison of diagnostic antibody production in perfusion stirred tank and in hollow fiber bioreactor processes. Biotechnol Prog 2011; 27: 1588-98.
87. Vishal A, Manjot B. Strategies for rapid production of therapeutics proteins in mammalian cells. Bioprocess Int 2012; 10: 32-48.
88. Foghsgaard C, Kjaer TMR, Soni NK. Cell culture media. WO2008009642, 2008.
89. Reiter M, Mundt W, Grillberger L, Kraus B. Animal protein free media for cultivation of cells. US20110217772, 2011.
90. Drews M, Rumvolt R, Voodla K. Use of extract of seleniumenriched yeast (SE-YE) in mammalian cell culture media formulations. US20110143432, 2011.
91. Gawlitzek M, Luo S, Petraglia CT. Production of proteins in glutamine-free cell culture media. US20110091936, 2011.
92. Landauer K, Waxenecker G. Novel cell culture medium supplements. WO2005095582, 2005.
93. Grillberger L, Reiter M, Mundt W, Mitterer A. Oligopeptide-free cell culture media. US20110151512, 2011.
94. Crowell CK, Grampp GE. Production of glycoprotein using manganese. US20070161084, 2007.
95. Follstad BD, Potter AH. Cell culture performance with betaine. US20110053265, 2011.
96. Jayapal KP, Wlaschin KF, Hu WS, Yap MG. Recombinant protein therapeutics from CHO cells-20 years and counting. Chem Eng Prog 2007; 103: 40-47.