Scaleable purification process for gene therapy retroviral vectors

Journal of Gene Medicine

Volumn 9, Issue 4, 2007, Pages 233-243

  Rodriques, Teresa ^a   Carvalho, Andreia ^a   Carmo, Marlene ^a   Carrondo, Manuel J T ^a,b   Alves, Paula M ^a   Cruz, Pedro E ^a  

^a INSTITUTO DE TECNOLOGIA QUÍMICA E BIOLÓGICA   (Portugal)

^b UNIVERSIDADE NOVA DE LISBOA   (Portugal)

Author keywords

Anion exchange chromatography; Gene therapy; Membrane separations; Purification; Retroviral vectors

Indexed keywords

2 DIETHYLAMINOETHANOL; RETROVIRUS VECTOR;

ANION EXCHANGE CHROMATOGRAPHY; ARTICLE; CONCENTRATION PROCESS; CONTROLLED STUDY; DIAFILTRATION; DOWNSTREAM PROCESSING; GENETIC TRANSDUCTION; HUMAN; HUMAN CELL; LEUKEMIA VIRUS; MEMBRANE FILTER; MICROFILTRATION; MOLECULAR WEIGHT; PRIORITY JOURNAL; PROCESS OPTIMIZATION; SCALE UP; SUPERNATANT; ULTRAFILTRATION; VALIDATION PROCESS; VIRAL GENE DELIVERY SYSTEM; VIRAL GENE THERAPY; VIRUS PURIFICATION;

ANIMALS; CELL LINE; CHROMATOGRAPHY, ION EXCHANGE; GENE THERAPY; GENETIC VECTORS; HUMANS; LEUKEMIA VIRUS, MURINE; MICE; QUALITY CONTROL; RETROVIRIDAE;

MURINAE;

EID: 34248526229     PISSN: 1099498X     EISSN: 15212254     Source Type: Journal    
DOI: 10.1002/jgm.1021     Document Type: Article

References (37)

1. Mountain A. Gene therapy: the first decade. Trends Biotechnol 2000; 18: 119-128.
2. Gene Therapy Clinical Trials Worldwide, 2006; Available: http://www.wiley.co.uk/genmed/clinical/, last accessed October 2006.
3. Rodrigues T, Carrondo MJ, Alves PM, Cruz PE. Purification of retroviral vectors for clinical application: Biological implications and technological challenges. J Biotechnol 2007; 127: 520-541.
4. Layne SP, Merges MJ, Dembo M, et al. Factors underlying spontaneous inactivation and susceptibility to neutralization of human immunodeficiency virus. Virology 1992; 189: 695-714.
5. Beer C, Meyer A, Muller K, Wirth M. The temperature stability of mouse retroviruses depends on the cholesterol levels of viral lipid shell and cellular plasma membrane. Virology 2003; 308: 137-146.
6. Merten OW. State-of-the-art of the production of retroviral vectors. J Gene Med 2004; 6(Suppl 1): S105-124.
7. Powell SK, Kaloss MA, Pinkstaff A, et al. Breeding of retroviruses by DNA shuffling for improved stability and processing yields. Nat Biotechnol 2000; 18: 1279-1282.
8. Burns JC, Friedmann T, Driever W, Burrascano M, Yee JK. Vesicular stomatitis virus G glycoprotein pseudotyped retroviral vectors: concentration to very high titer and efficient gene transfer into mammalian and nonmammalian cells. Proc Natl Acad Sci USA 1993; 90: 8033-8037.
9. Kempken R, Preissmann A, Berthold W. Clarification of animal cell cultures on a large scale by continuous centrifugation. J Ind Microbiol 1995; 14: 52-57.
10. Transfiguracion J, Jaalouk DE, Ghani K, Galipeau J, Kamen A. Size-exclusion chromatography purification of high-titer vesicular stomatitis virus G glycoprotein-pseudotyped retrovectors for cell and gene therapy applications. Hum Gene Ther 2003; 14: 1139-1153.
11. Segura MM, Kamen A, Trudel P, Garnier A. A novel purification strategy for retrovirus gene therapy vectors using heparin affinity chromatography. Biotechnol Bioeng 2005; 90: 391-404.
12. Reeves L, Cornetta K. Clinical retroviral vector production: step filtration using clinically approved filters improves titers. Gene Ther 2000; 7: 1993-1998.
13. Przybylowski M, Hakakha A, Stefanski J, Hodges J, Sadelain M, Riviere I. Production scale-up and validation of packaging cell clearance of clinical-grade retroviral vector stocks produced in cell factories. Gene Ther 2006; 13: 95-100.
14. Le Doux JM, Morgan JR, Yarmush ML. Removal of proteoglycans increases efficiency of retroviral gene transfer. Biotechnol Bioeng 1998; 58: 23-34.
15. Landazuri N, Le Doux JM. Complexation with chondroitin sulfate C and Polybrene rapidly purifies retrovirus from inhibitors of transduction and substantially enhances gene transfer. Biotechnol Bioeng 2006; 93: 146-158.
16. Landazuri N, Gupta M, Le Doux JM. Rapid concentration and purification of retrovirus by flocculation with Polybrene. J Biotechnol 2006; 125: 529-539.
17. Zhang B, Xia HQ, Cleghorn G, Gobe G, West M, Wei MQ. A highly efficient and consistent method for harvesting large volumes of high-titre lentiviral vectors. Gene Ther 2001; 8: 1745-1751.
18. Hughes C, Galea-Lauri J, Farzaneh F, Darling D. Streptavidin paramagnetic particles provide a choice of three affinity-based capture and magnetic concentration strategies for retroviral vectors. Mol Ther 2001; 3: 623-630.
19. Williams SL, Nesbeth D, Darling DC, Farzaneh F, Slater NKH. Affinity recovery of Moloney Murine Leukaemia Virus. J Chromatogr B Biomed Sci Appl 2005; 820: 111-119.
20. Ye K, Jin S, Ataai MM, Schultz JS, Ibeh J. Tagging retrovirus vectors with a metal binding peptide and one-step purification by immobilized metal affinity chromatography. J. Virol 2004; 78: 9820-9827.
21. McGrath M, Witte O, Pincus T, Weissman IL. Retrovirus purification: method that conserves envelope glycoprotein and maximizes infectivity. J Virol 1978; 25: 923-927.
22. Rodrigues T, Carvalho A, Roldao A, Carrondo MJT, Alves PM, Cruz PE. Screening anion-exchange chromatographic matrices for isolation of onco-retroviral vectors. J Chromatogr B Analyt Technol Biomed Life Sci 2006; 837: 59-68.
23. Richieri SP, Bartholomew R, Aloia RC, et al. Characterization of highly purified, inactivated HIV-1 particles isolated by anion exchange chromatography. Vaccine 1998; 16: 119-129.
24. Yamada K, McCarty DM, Madden VJ, Walsh CE. Lentivirus vector purification using anion exchange HPLC leads to improved gene transfer. Biotechniques 2003; 34: 1074-1078, 1080.
25. Arnau J, Lauritzen C, Petersen GE, Pedersen J. Current strategies for the use of affinity tags and tag removal for the purification of recombinant proteins. Protein Expr Purif 2006; 48: 1-13.
26. Pizzato M, Merten OW, Blair ED, Takeuchi Y. Development of a suspension packaging cell line for production of high titre, serum-resistant murine leukemia virus vectors. Gene Ther 2001; 8: 737-745.
27. Morgan JR, Lee J, Tompkins RG, Yarmush ML. Rapid quantitation of recombinant retroviruses. Biotechnol Prog 1994; 10: 441-446.
28. Paul RW, Morris D, Hess BW, Dunn J, Overell RW. Increased viral titer through concentration of viral harvests from retroviral packaging lines. Hum Gene Ther 1993; 4: 609-615.
29. Cruz PE, Goncalves D, Almeida J, Moreira JL, Carrondo MJ. Modeling retrovirus production for gene therapy. 2. Integrated optimization of bioreaction and downstream processing. Biotechnol Prog 2000; 16: 350-357.
30. Kuiper M, Sanches RM, Walford JA, Slater NK. Purification of a functional gene therapy vector derived from Moloney murine leukaemia virus using membrane filtration and ceramic hydroxyapatite chromatography. Biotechnol Bioeng 2002; 80: 445-453.
31. Hammarstedt M, Wallengren K, Pedersen KW, Roos N, Garoff H. Minimal exclusion of plasma membrane proteins during retroviral envelope formation. Proc Natl Acad Sci USA 2000; 97: 7527-7532.
32. Morenweiser R. Downstream processing of viral vectors and vaccines. Gene Ther 2005; 12(Suppl 1): S103-110.
33. Williams SL, Eccleston ME, Slater NK. Affinity capture of a biotinylated retrovirus on macroporous monolithic adsorbents: towards a rapid single-step purification process. Biotechnol Bioeng 2005; 89: 783-787.
34. Carmo M, Faria TQ, Falk H, et al. Relationship between retroviral vector membrane and vector stability. J Gen Virol 2006; 87: 1349-1356.
35. O'Keeffe RS, Johnston MD, Slater NK. The affinity adsorptive recovery of an infectious herpes simplex virus vaccine. Biotechnol Bioeng 1999; 62: 537-545.
36. Le Doux JM, Morgan JR, Snow RG, Yarmush ML. Proteoglycans secreted by packaging cell lines inhibit retrovirus infection. J Virol 1996; 70: 6468-6473.
37. Kustikova OS, Wahlers A, Kuhlcke K, et al. Dose finding with retroviral vectors: correlation of retroviral vector copy numbers in single cells with gene transfer efficiency in a cell population. Blood 2003; 102: 3934-3937.