Biochemical recovery and purification of gene therapy vectors

Current Opinion in Biotechnology

Volumn 9, Issue 2, 1998, Pages 177-185

  Lyddiatt, Andrew ^a   O'Sullivan, Deirdre A ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

NANOPARTICLE;

BIOENGINEERING; BIOMEDICAL ENGINEERING; CELL CULTURE; EXPRESSION VECTOR; FRACTIONATION; GENE THERAPY; PRIORITY JOURNAL; PROCESS CONTROL; REVIEW;

EID: 0031923947     PISSN: 09581669     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0958-1669(98)80112-2     Document Type: Article

References (48)

1. Russell SJ. Gene therapy - science, medicine and the future. Br Med J. 315:1997;1289-1292.
2. Kovesdsi I, Brough DE, Bruder T, Whickham TJ. Adenoviral vectors for gene transfer. Curr Opin Biotechnol. 8:1997;583-590.
3. Davis HL. Plasmid DNA expression systems for the purpose of immunization. Curr Opin Biotechnol. 8:1997;635-640.
4. Lundstrom K. Alphaviruses as expression vectors. Curr Opin Biotechnol. 8:1997;578-582.
5. Ledley F. Non-viral gene therapy: the promise as pharmaceutical products. Hum Gen Ther. 6:1995;1129-1144.
6. Hodgson CP. The vector void in gene therapy - can viral vectors and transfection be combined to permit safe, efficacious and targeted gene therapy? Bio/Technology. 13:1995;222-225.
7. Braas G, Searle PF, Slater NKH, Lyddiatt A. Strategies for the isolation and purification of retroviral vectors for gene therapy. of special interest Bioseparation. 6:1996;211-228 Based upon a review of the likely productive titres of retrovirus, pragmatic consideration is given to the suitability of scaleable unit operations for the recovery in Good Manufacturing Practice recovery of clinically-approved vectors. Urgent requirements for the development and validation of more selective methods, based upon a mechanistic understanding of particle behaviour in two-phase systems, are identified.
8. Marquet M, Horn NA, Meek JA. Process development for the manufacture of plasmid DNA vectors for use in gene therapy. Biopharm. 1995;26-37. September.
9. Bowles NE, Eisensmith RC, Mohuddin R, Pyron M, Woo SLC. A simple and efficient method for the concentration and purification of recombinant retrovirus for increased hepatocyte transduction in vivo. Hum Gen Ther. 7:1996;1735-1742.
10. Prazeres DM, Schluep T, Cooney C. Preparative purification of supercoiled plasmid DNA using anion-exchange chromatography. of outstanding interest J Chromatogr A. 1998; Method development of anion-exchange chromatographic recovery of supercoiled plasmid DNA is described at three scales (1, 10 and 40 ml beds), and performance data presented based upon anion-exchange HPLC analyses. The impact of working capacity upon the quality of recovered product is critically discussed.
11. Carlson A, Signs M, Lierman L, Boor R, Jim Jem K. Mechanical disruption of Escherichia coli for plasmid recovery. Biotech Bioeng. 48:1995;303-315.
12. Wong HH, O'Neill BK, Middleberg APJ. Centrifugal processing of cell debris and inclusion bodies from recombinant Escherichia coli. Bioseparation. 6:1997;361-372.
13. Renaner U, Jonsson AS. Cell harvesting by cross-flow filtration using a shear-enhanced module. Biotech Bioeng. 52:1996;539-548.
14. Walker SG, Lyddiat A. Aqueous two-phase systems as an alternative process route for the fractionation of small inclusion bodies. of special interest J Chromatogr B. 1998; The practical simplicity and value of aqueous two-phase systems (ATPS) is demonstrated in the direct recovery of small inclusion bodies (150 nm) from homogenates of E coli. Performance compares favourably with scale-limited processes of ultracentrifugation, and invites the application of ATPS with other nanoparticulate products.
15. Hjorth R. Expanded-bed adsorption in industrial processing: recent developments. of special interest Trends Biotechnol. 15:1997;230-235 Performance of adsorbents, feedstock contactors and modes of operation are described in the industrial scale recovery of protein products from particulate feedstocks. Generic applications for other products (both intra- and extracellular) sourced in bacteria, yeasts or animal cells are clearly indicated.
16. Huddleston JG, Lyddiatt A. Two-phase aqueous systems for the recovery of intracellular microbial products. of special interest Verrall M. Downstrean Processing of Natural Products: a Practical Handbook. 1996;53-70 John Wiley and Sons, New York, Exploiting yeast intracellular proteins as the demonstration vehicle, a pragmatic account is offered of the strategic and practical points to be considered in the de novo design and implementation of working systems to recovery of target products from particulate feedstocks. Options for the recovery of nanoparticle and recycling of phase-forming chemicals are indicated.
17. Ferreira GNM, Cabral JMS, Prazeres DMF. A comparison of gel filtration chromatographic supports for plasmid purification. Biotech Tech. 11:1997;417-420.
18. Forestell SP, Bohnlein E, Rigg RJ. Retroviral end-point titer is not predictive of gene transfer efficiency: implication for vectors production. Gene Ther. 2:1995;1-8.
19. Prior CP, Gore R, Harter J, Berbaumn M, Duffy C, Ferre F, Hancock R, Lowry P, Musil R, Stiglitz M, et al. Inactivation and purification of human immunodeficiency virus-1 as antigen for the treatment of HIV-1 infection. of special interest Biopharm. 9:1996;22-30 Uniquely in the time-frame of the review, the only paper to present any performance data for large-scale (7.5-15 litre beds) ion exchange chromatography for the recovery of a viral product. Interesting use of centrifugation as a final concentration step prior to cobalt irradiation and formulation.
20. Hughye B, Xiadong L, Sutjipto S, Sugarman BJ, Hom MK, Shepard M, Scandella CJ, Shabram P. Purification of a type 5 recombinant adenovirus encoding human p53 by column chromatography. Hum Gen Ther. 6:1995;1403-1416.
21. Schorr J, Moritz P, Seddon T, Schleef M. Plasmid DNA for gene therapy and DNA vaccines. Ann NY Acad Sci. 772:1995;271-273.
22. Ion exchange chromatography - principles and methods. Uppsala: Pharmacia Biotech. 1997.
23. Huddleston JG, Abelaira J-C, Wang R, Lyddiatt A. Protein partition between different phases comprising poly(ethylene glycol)-salt aqueous two-phase systems, hydrophobic interaction chromatography and precipitation: a generic description in terms of salting-out effects. J Chromatogr. B680:1996;31-41.
24. Perseptive Biosystems Optimization of monoclonal antibody purification from ascites; rapid method development. Application Note PA415. 1995;Perseptive Biosystems Inc, Framingham MA USA.
25. Karnas P, Lindblom T. Characterisation of hydrophobic interaction and HIC media by multivariate analysis. J Chromatography. 599:1992;131-136.
26. Escriou V, Lagineaux D, Crouzel J, Wils P, Scherman D. Triple helix formation on plasmid DNA determined by a size-exclusion chromatographic method. Anal Biochem. 248:1997;102-110.
27. Douglas JT, Rogers BE, Rosenfeld ME, Michael SI, Feng M, Curiel DT. Targeted gene delivery by tropism-modified adenoviral vectors. Nat Biotechnol. 14:1996;1574-1578.
28. O'Neill PF, Balovic ES. Virus harvesting and affinity-based liquid chromatography - a method for virus concentration and purification. Bio/Technology. 11:1993;173-178.
29. White EM, Grun JB, Sun C-S, Sito AF. Process validation for virus removal and activation. Biopharm. 1991, May;23-27.
30. Johansson HJ, Jagersten C, Shiloach J. Large-scale recovery and purification of periplasmic recombinant protein from E coli using expanded bed adsorption chromatography followed by new ion exchange media. JH Biotechnol. 48:1996;9-14.
31. Chase HA. Affinity separations utilising immobilised monoclonal antibodies: a new tool for the biochemical engineer. Chem Eng Sci. 39:1984;1099-1125.
32. Hubble J. Affinity cell separations: problems and prospects. Trends Biotechnol. 15:1997;249-255.
33. Desvoyes B, Dulieu P. Purification by monoclonal; antibody affinity chromatography of virus-like particles associated with '447' cytoplasmic male sterility of Vicia faba and investigation of their antigenic composition. Plant Sci. 116:1996;239-246.
34. Mathew GB, Hitchcock AG, Varley DL, Hanak JAJ, Thatcher DR. Production of plasmid DNA for non-viral gene therapy. of special interest Proc US Soc Indust Microbiol. 1996; An outline description of a complete, prototype working process for plasmid manufacture, including the use of expanded bed, anion-exchange chromatography and gel-filtration.
35. Gustavsson P-E, Larsson P-O. Super-porous agarose: a new material for chromatography. J Chromatogr. A734:1996;231-240.
36. Rapid, preparative purification of plasmid DNA by anion exchange perfusion chromatography. Application Note PA428. 1966;Perseptive Biosystems Inc, Framingham MA USA.
37. Green AP, Prior GM, Helveston NM, Tattinger BE, Liu X, Thompson JA. Preparative purification of supercoiled plasmid DN for therapeutic applications. Biopharm. 10:1997;52-62.
38. Zhu J, Lyddiatt A, Pacek AW, Nienow AW. Fabrication and characterisation of agar/zircon sand composite adsorbents for protein recovery in liquid fluidised beds. of special interest Nienow AW. Bioreactor/process Fluid Dynamics. 1997;103-114 BHR Group/Mech Eng Publications, London, Outline description of a novel coating process to generate prototype pellicular adsorbent solid phases suited to high on/off-rates of selective, product adsorption in fluidised bed contactors fed with particulate feedstocks.
39. Mohan SB, Lyddiatt A. Recent developments in affinity separation technologies. Matejschuk P. Affinity Separations; a Practical Approach. 1997;1-36 Oxford University Press, Oxford.
40. Thoemmes J. Fluidized bed adsorption as a primary recovery step in protein purification. of special interest Adv Biochem Eng. 58:1997;185-230 A very thorough, quantitative description of the process and the key parameters exploitable in operational control, coupled with accounts of applications undertaken for the products of bacteria, yeast, mammalian and other sources.
41. Hjorth R, Kampe S, Carlsson M. Analysis of some operating parameters of novel adsorbents for recovery of proteins in expanded beds. Bioseparation. 5:1995;217-223.
42. O'Brien SM, Thomas ORT, Dunnill P. Non-porous magnetic chelator supports for protein recovery by immobilised metal affinity adsorption. J Biotechnol. 50:1996;12-25.
43. Walker SG, Dale CJ, Lyddiatt A. Aqueous two-phase partition of complex protein feedstocks derived from brain tissue homogenates. J Chromatography. B680:1996;91-96.
44. Hammar L. Concentration of biomaterials: virus concentration and virus protein isolation. Methods Enzymol. 228:1994;640-658.
45. Andrews BA, Huang RB, Asenjo J. Purification of virus like particles from yeast cells using aqueous two-phase systems. Bioseparation. 5:1995;105-112.
46. Giddings JC. Field flow fractionation: analysis of macromolecular colloidal and particulate materials. Science. 260:1993;1456-1465.
47. Williams SKR, Raner GM, Ellis WR Jr, Giddings JC. Separation of protein inclusion bodies from E coli lysates using sedimentation field-flow fractionation. J Microcol Sep. 1998;. in press.
48. Noble PT. Evaluation of rotational flow stabilised continuous electrophoresis for protein fractionation. Biotech Prog. 1:1985;237-249.