Basic Issues in the Manufacture of Macromoleucles

Handbook of Pharmaceutical Biotechnology

Volumn , Issue , 2006, Pages 297-317

  Lengsfeld, Corinne ^a   Anchordoquy, Thomas ^b,c  

^a University of Denver   (United States)

^b UNIVERSITY OF COLORADO   (United States)

^c UNIVERSITY OF DENVER   (United States)

Author keywords

Example process atomization; Introduction to bioprocessing; Manufacturing concerns

Indexed keywords

EID: 68749089422     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470117118.ch4a     Document Type: Chapter

References (58)

1. Hatti-Kaul R, Mattiasson B, eds. (2003). Isolation and Purification of Protiens. 1st ed.: Marcel Dekker Inc, New York, pp. ix-xvii.
2. Prazeres D M, Ferreira G N, Monteiro G A, et al. (1999). Large-scale production of pharmaceutical-grade plasmid DNA for gene therapy: problems and bottlenecks. Trends in Biotechnol. 17:169-174.
3. Durland R H, Eastman E M (1998). Manufacturing and quality control of plasmidbased gene expression systems. Adv. Drug. Deliv. Rev. 30:33-48.
4. Sanghvi Y S, Schulte M (2004). Therapeutic oligonucleotides: The state-of-the-art in purification technologies. Curr. Opin. Drug. Discov. Devel. 7(6):765-776.
5. Lindahl T (1993). Instability and decay of the primary structure of DNA. Nature. 362:709-715.
6. Lindahl T, Andersson A (1972). Rate of chain breakage at apurinic sites in doublestranded deoxyribonucleic acid. Biochem. 11:3618-3623.
7. Lindahl T, Nyberg B (1972). Rate of depurination of native deoxyribonucleic acid. Biochem. 11:3610-3618.
8. Evans R K, Xu Z, Bohannon K E, et al. (2002). Evaluation of degradation pathways for plasmid DNA in pharmaceutical formulations via accelerated stability studies. J. Pharmac. Sci. 89:76-87.
9. Chi E Y, Krishnan S, Randolph T W, et al. (2003). Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation. Pharmac. Res. 20(9):1325-1336.
10. Tservistas M, Levy M S, Lo-Yim M Y A, et al. (2001). The formation of plasmid DNA loaded pharmaceutical powders using supercritical fluid technology. Biotechnol. Bioengin. 72:12-18.
11. Breen A P, Murphy J A (1995). Reactions of oxyl radicals with DNA. Free Radical Biol. Med. 18:1033-1077.
12. Graf E, Mahoney J R, Bryant R G, et al. (1984). Iron-catalyzed hydroxyl radical formation. Stringent requirement for free iron coordination site. J. Biol. Chem. 259:3620-3624.
13. Keyer K, Imlay J A (1996). Superoxide accelerates DNA damage by elevating free-iron levels, Proc. of the National Academy of Sciences USA. 93:13635-13640.
14. Luo Y, Han Z, Chin S M, et al. (1994). Three chemically distinct types of oxidants formed by iron-mediated Fenton reactions in the presence of DNA, Proc. of the National Academy of Sciences USA. 91:12438-12442.
15. Middaugh C R, Evans R K, Montgomery D L, et al. (1999). Analysis of plasmid DNA from a pharmaceutical perspective. J. Pharmac. Sci. 87:130-146.
16. Cowan J A (1998). Metal activation of enzymes in nucleic acid biochemistry. Chem. Rev. 98:1067-1087.
17. Frenkel J (1994). Orientation and rupture of linear macromolecules in dilute solutions under the influence of viscous flow. Acta Physicochim. USSR. 19:51-76.
18. Davison P F (1959). The effect of hydrodynamic shear on the deoxyribonucleic acid from T2 and T4 bacteriophages, Proc. of the National Academy of Science. 45:1560-1568.
19. Levinthal C, Davison P F (1961). Degradation of deoxyribonucleic acid hydrodynamic shearing forces. J. Molec. Biol. 3:674-683.
20. Bowman R D, Davidson N (1972). Hydrodynamic shear breakage of DNA. Biopolymers. 11:2601-2624.
21. Lengsfeld C S, Anchordoquy T J (2002). Shear-induced degradation of plasmid DNA. J. Pharmac. Sci. 91:1581-1589.
22. Yim S S, Shamlou P A (2000). The engineering effects of fluids flow on freely suspended biological macro-materials and macromolecules. Adv. Biochem. Engin. /Biotechnol. 67:83-122.
23. Worden L (2005). Degradation behavior of genomic DNA during bioprocessing. Masters Thesis, University of Denver, Denver, C.O., pp. 69-73.
24. De Gennes P G (1974). Coil-stretch transition of dilute flexible polymers under ultrahigh velocity gradients. J. Chem. Phys. 60(12):5030-5042.
25. Larson R G, Magda J J (1989). Coil-stretch transitions in mixed shear and extensional flows of dilute polymer solutions. Macromo. 22(7):3004-3010.
26. Perkins T T, Smith D E, Chu S (1977). Single polymer dynamics in an elongation flow. Science. 276:2016-2021.
27. Smith D E, Chu S (1998). Response of flexible polymers to a sudden elongation flow. Science. 281:1335-1340.
28. LeDuc P, Haber C, Bao G, et al. (1999). Dynamics of individual flexible polymers in a shear flow. Nature. 399:564-566.
29. Hur J S, Shaqfeh E S G, Babcock H P, et al. (2002). Dynamics and configurational fluctuations of single DNA molecules in linear mixed flows. Phys. Rev. E. 66(1):Pt 1, 011915.
30. Lumley J L (1973). Drag reduction in turbulent flow by polymer additives. J. Polymer Sci. Part D: Macromolecular Review, 7(1):263-290.
31. Balkovsky E, Fouxon A, Lebedev V (2001). Turbulence of polymer solutions. Phys. Rev. E. 64:056301:1-14.
32. Thiffeault J (2003). Finite extension of polymers in turbulent flow. Phys. Lett. A:308:445-450.
33. Kundu P K, Cohen I M (2002). Fluid Mechanics, 2nd ed.: Academic Press, San Diego, C.A., pp. 438-440.
34. Lentz Y, Anchordoquy T A, Lengsfeld C S (2006). DNA acts as a nucleation site for transient cavitation in ultrasonic nebulizers. J. Pharmac. Sci. 95(3):607-619.
35. Levy M S, O'Kennedy R D, Ayazi-Shamlou P, et al. (2000). Biochemical engineering approaches to the challenges of producing pure plasmid DNA. Trends in Biotechnol. 18:296-305.
36. Maa Y F, Nguyen P A, Hsu S W (1998). Spray-drying of air-liquid interface sensitive recombinant human growth hormone. J. Pharmac. Sci. 87:152-159.
37. Maa Y F, Hsu C C (1997). Protein denaturation by combined effect of shear and airliquid interface. Biotechnol. Bioengin. 54:503-512.
38. Levy M S, Collins I J, Yim S S, et al. (1999). Effect of shear on plasmid DNA in solution. Bioproc. Engin. 20:7-13.
39. Imlay J A, Linn S (1988). DNA damage and oxygen radical toxicity. Science. 240:1302-1309.
40. Lentz Y, Worden L, Anchordoquy T A, et al. (2005). Impact of jet nebulization of plasmid DNA: degradation mechanism and mitigation methods. J. Aerosol Sci. 36:973-990.
41. Malmsten M ed. (2003). Biopolymers at Interfaces, 2nd ed.: Marcel Dekker Inc, New York.
42. Chou D K, Krishnamurthy R, Randolph T W, et al. (2005). Effects of Tween 20 and Tween 80 on the stability of albutropin during agitation. J. Pharmac. Sci. 94(6): 1368-1381.
43. Kim Y S, Jones L S, Dong A, et al. (2003). Effects of sucrose on conformational equilibria and fluctuations within the native-state ensemble of proteins. Protein Sci. 12:1251-1261.
44. Kendrick B S, Carpenter J P, Cleland J L, et al. (1998). A transient expansion of the native state precedes aggregation of recombinant human interferon-γ, Proc. of the National Academy of Science USA. 95:14142-14146.
45. Teare D O H, Barwick D C, Schofield W C E (2005). Functionalization of Solid Surfaces with Thermoresponsive Protein-Resistant Films. J. Phys. Chem. B. 109:22407-22412.
46. DeFife K M, Hagen K M, Clapper D L, et al. (1999). Photochemically immobilized polymer coatings: effects on protein adsorption, cell adhesion, and leukocyte activation. Journal of Biomaterials Science. Polymer Edition. 10(10):1063-1074.
47. Lentz Y, Anchordoquy T J, Lengsfeld C S (2006). Impact of Aerosolization Devices on plasmid DNA. J. Aerosol Med. In Press.
48. Gomez A, Bingham D, de Juan L, et al. (1998). Production of protein nanoparticles by electrospray drying. J. Aerosol Sci. 29(5-6):561-574.
49. Huang M F, Kuo Y C, Huang C C, et al. (2004). Separation of long double-stranded DNA by nanoparticle filled capillary electrophoresis. Anal. Chem. 76(1):192-196.
50. Chou C F, Bakajin O, Turner S W, et al. (1999). Sorting by diffusion: An asymmetric obstacle course for continuous molecular separation. Proc. Natl. Acad. Sci. USA. 96(24):13762-13765.
51. Kaji N, Tezuka Y, Takamura Y, et al. (2004). Separation of long DNA molecules by quartz nanopillar chips under a direct current electric field. Anal. Chem. 76(1): 15-22.
52. Cole K D, Tellez C M (2002). Separation of large circular DNA by electrophoresis in agarose gels. Biotechnol. Prog. 18(1):82-87.
53. Bakajin O, Duke T A I, Tegenfeldt J, et al. (2001). Separation of 100-kilobase DNA molecules in 10 seconds. Anal. Chem. 73(24):6053-6056.
54. Han J, Craighead H G (2000). Separation of long DNA molecules in a micro fabricated entropic trap array. Science. 288(5468):1026-1029.
55. Turner S W P, Cabodi M, Craighead H G (2002). Confinement-induced entropic recoil of single DNA molecules in nanofluidic structure. Phys. Rev. Let. 88(12):128103.
56. Cabodi M, Turner S W P, Craighead H G (2002). Entropic recoil separation of long DNA molecules. Anal. Chem. 74:5169-5174.
57. Foquet M, Korlach J, Zipfel W, et al. (2002). DNA fragment sizing by single molecule detection in submicrometer sized closed fluidic channels. Anal. Chem. 74:1415-1422.
58. Yi Y B, Lengsfeld C S (2006). Mechanical modeling of a CA molecule motion in simple channels. J. Applied Phy. In Press.