Process Development of Adenoviral Vector Production in Fixed Bed Bioreactor: From Bench to Commercial Scale

Human Gene Therapy

Volumn 26, Issue 8, 2015, Pages 560-571

  Lesch, Hanna P ^a,b,c   Heikkilä, Kati M ^b   Lipponen, Eevi M ^a,b   Valonen, Piia ^b   Müller, Achim ^b   Räsänen, Eva ^b   Tuunanen, Tarja ^b   Hassinen, Minna M ^a,b   Parker, Nigel ^a,b   Karhinen, Minna ^b   Shaw, Robert ^a,b,c   Ylä Herttuala, Seppo ^c,d  

^a FKD Therapies Oy   (Finland)

^b FinVector Vision Therapies Oy   (Finland)

^c UNIVERSITY OF EASTERN FINLAND   (Finland)

^d KUOPIO UNIVERSITY HOSPITAL   (Finland)

Author keywords

[No Author keywords available]

Indexed keywords

ADENOVIRUS VECTOR; CULTURE MEDIUM;

ARTICLE; BIOMASS; CELL COUNT; CELL DENSITY; CELL GROWTH; CELL SUSPENSION; CELLULAR DISTRIBUTION; CONTROLLED STUDY; FIXED BED REACTOR; GLUCOSE INTAKE; HEK293 CELL LINE; HUMAN; HUMAN CELL; NONHUMAN; PROCESS DEVELOPMENT; SCALE UP; VIRUS PARTICLE; ADENOVIRIDAE; BIOREACTOR; CELL PROLIFERATION; CULTURE MEDIUM; GENE VECTOR; PHYSIOLOGY; VIRUS CULTURE; VIRUS REPLICATION;

ADENOVIRIDAE;

ADENOVIRIDAE; BIOREACTORS; CELL PROLIFERATION; CULTURE MEDIA; GENETIC VECTORS; HEK293 CELLS; HUMANS; VIRUS CULTIVATION; VIRUS REPLICATION;

EID: 84939814373     PISSN: 10430342     EISSN: 15577422     Source Type: Journal    
DOI: 10.1089/hum.2015.081     Document Type: Article

References (31)

1. Hackett NR, Crystal RG. Adenovirus vectors for gene therapy. In: Gene and Cell Therapy, 2nd edition. NS Templeton, ed. (Marcel Dekker, Inc., New York, NY). 2004; pp.17-42.
2. Gao GP, Yang Y, Wilson JM. Biology of adenovirus vectors with E1 and E4 deletions for liverdirected gene therapy. J. Virol. 1996;70:8934-8943.
3. Lusky M, Christ M, Rittner K, et al. In vitro and in vivo biology of recombinant adenovirus vectors with E1, E1/E2A, or E1/E4 deleted. J. Virol. 1998; 72:2022-2032.
4. Kochanek S, Schiedner G, Volpers C. Highcapacity ''gutless'' adenoviral vectors. Curr Opin Mol Ther 2001;3:454-463.
5. de Cassan SC, Draper SJ. Recent advances in antibody-inducing poxviral and adenoviral vectored vaccine delivery platforms for difficult disease targets. Expert Rev Vaccines 2013;12: 365-378.
6. Salmon F, Grosios K, Petry H. Safety profile of recombinant adeno-associated viral vectors: Focus on alipogene tiparvovec (Glybera(R)). Expert Rev Clin Pharmacol 2014;7:53-65.
7. Vellinga J, Smith JP, Lipiec A, et al. Challenges in manufacturing adenoviral vectors for global vaccine product deployment. Hum Gene Ther 2014; 25:318-327.
8. Stacey GN, Merten OW. Host cells and cell banking. Methods Mol Biol 2011;737:45-88.
9. Iyer P, Ostrove JM, Vacante D. Comparison of manufacturing techniques for adenovirus production. Cytotechnology 1999;30:169-172.
10. Wu SC, Huang GY, Liu JH. Production of retrovirus and adenovirus vectors for gene therapy: A comparative study using microcarrier and stationary cell culture. Biotechnol Prog 2002;18:617-622.
11. Dormond E, Perrier M, Kamen A. From the first to the third generation adenoviral vector: What parameters are governing the production yield? Biotechnol Adv 2009;27:133-144.
12. Meuwly F, Ruffieux PA, Kadouri A, et al. Packedbed bioreactors for mammalian cell culture: Bioprocess and biomedical applications. Biotechnol Adv 2007;25:45-56.
13. Lennaertz A, Knowles S, Drugmand JC, et al. Viral vector production in the integrity- iCELLis- single-use fixed-bed bioreactor, from bench-scale to industrial scale. BMC Proc 2013;7:59-60.
14. Wang X, Olszewska M, Qu J, et al. Large-scale clinical-grade retroviral vector production in a fixed-bed bioreactor. J Immunother 2015;38:127-135.
15. Rajendran R, Lingala R, Vuppu SK, et al. Assessment of packed bed bioreactor systems in the production of viral vaccines. AMB Express 2014; 4:25.
16. Shabram PW, Giroux DD, Goudreau AM, et al. Analytical anion-exchange HPLC of recombinant type-5 adenoviral particles. Hum Gene Ther 1997; 8:453-465.
17. Liste-Calleja L, Lecina M, Cairo JJ. HEK293 cell culture media study towards bioprocess optimization: Animal derived component free and animal derived component containing platforms. J Biosci Bioeng 2014;117:471-477.
18. Kamen A, Henry O. Development and optimization of an adenovirus production process. J Gene Med 2004;6:S184-S192.
19. Ferreira TB, Ferreira AL, Carrondo MJ, et al. Effect of re-feed strategies and non-ammoniagenic medium on adenovirus production at high cell densities. J Biotechnol 2005;119:272-280.
20. Cortin V, Thibault J, Jacob D, et al. High-titer adenovirus vector production in 293S cell perfusion culture. Biotechnol Prog 2004;20:858-863.
21. Liu H, Liu XM, Li SC, et al. A high-yield and scaleable adenovirus vector production process based on high density perfusion culture of HEK 293 cells as suspended aggregates. J Biosci Bioeng 2009;107:524-529.
22. Iyer P, Ostrove JM, Vacante D. Comparison of manufacturing techniques for adenovirus production. Cytotechnology 1999;30:169-172.
23. Rodrigues AF, Carmo M, Alves PM, et al. Retroviral vector production under serum deprivation: The role of lipids. Biotechnol Bioeng 2009;104: 1171-1181.
24. Petiot E, Cuperlovic-Culf M, Shen CF, et al. Influence of HEK293 metabolism on the production of viral vectors and vaccine. Vaccine 2015. [Epub ahead of print]; doi: 10.1016/j.vaccine.2015.05.097.
25. Liu H, Liu XM, Li SC, et al. A high-yield and scaleable adenovirus vector production process based on high density perfusion culture of HEK 293 cells as suspended aggregates. J Biosci Bioeng 2009;107:524-529.
26. Dormond E, Kamen AA. Manufacturing of adenovirus vectors: Production and purification of helper dependent adenovirus. Methods Mol Biol 2011;737:139-156.
27. Levy DE, Garcia-Sastre A. The virus battles: IFN induction of the antiviral state and mechanisms of viral evasion. Cytokine Growth Factor Rev 2001; 12:143-156.
28. Kaufman JB, Wang G, Zhang W, et al. Continuous production and recovery of recombinant Ca2 + binding receptor from HEK 293 cells using perfusion through a packed bed bioreactor. Cytotechnology 2000;33:3-11.
29. Iyer P, Ostrove JM, Vacante D. Comparison of manufacturing techniques for adenovirus production. Cytotechnology 1999;30:169-172.
30. Lennaertz A, Knowles S, Drugmand JC, et al. Viral vector production in the integrity- iCELLis- single-use fixed-bed bioreactor, from bench-scale to industrial scale. BMC Proc 2013;7:59-60.
31. Wang X, Olszewska M, Qu J, et al. Large-scale clinical-grade retroviral vector production in a fixedbed bioreactor. J Immunother 2015;38:127-135.