Large-scale adenovirus and poxvirus-vectored vaccine manufacturing to enable clinical trials

Biotechnology Journal

Volumn 10, Issue 5, 2015, Pages 741-747

  Kallel, Héla ^a   Kamen, Amine A ^b  

^a PASTEUR INSTITUTE OF TUNIS   (Tunisia)

^b MCGILL UNIVERSITY   (Canada)

Author keywords

Adenovirus; Clinical trials; Poxvirus; Process development; Vectored vaccines

Indexed keywords

CELL CULTURE; MANUFACTURE; VACCINES; VECTORS;

ADENOVIRUS; CLINICAL TRIAL; DOWNSTREAM-PROCESSING; HETEROLOGOUS EXPRESSION; LARGE SCALE PRODUCTIONS; MANUFACTURING METHODS; POXVIRUS; PROCESS DEVELOPMENT;

DISEASES;

ADENOVIRUS VECTOR; CANCER VACCINE; POXVIRUS VECTOR; VIRUS VACCINE;

CELL CULTURE; CELL DENSITY; CELL DISRUPTION; DNA CONTENT; DOWNSTREAM PROCESSING; DRUG MANUFACTURE; GENE TARGETING; LARGE SCALE PRODUCTION; NONHUMAN; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PURIFICATION; REVIEW; VACCINATION; VIRUS LOAD; VIRUS PARTICLE; ADENOVIRIDAE; BATCH CELL CULTURE; BIOSYNTHESIS; CELL COUNT; CLINICAL TRIAL (TOPIC); GENE VECTOR; GENETICS; HUMAN; IMMUNOLOGY; POXVIRIDAE; PROCEDURES; VIRUS CULTURE;

ADENOVIRIDAE; POXVIRIDAE;

ADENOVIRIDAE; BATCH CELL CULTURE TECHNIQUES; CELL COUNT; CLINICAL TRIALS AS TOPIC; GENETIC VECTORS; HUMANS; POXVIRIDAE; VIRAL VACCINES; VIRUS CULTIVATION;

EID: 84928827739     PISSN: 18606768     EISSN: 18607314     Source Type: Journal    
DOI: 10.1002/biot.201400390     Document Type: Review

References (58)

1. Bae, K. D., Choi, J. Y., Jang, Y. S., Ahn, S., Hur, B., Innovative vaccine production technologies: The evolution and value of vaccine production technologies. Arch. Pharm. Res. 2009, 4, 465-480.
2. Nieto, K., Salvetti, A., AAV vectors vaccines against infectious diseases. Frontiers in Immunol. 2014, 5, 1-9.
3. Liu, M. A., Immunologic basis of vaccine vectors. Immunity 2010, 33, 504-515.
4. Rollier, C. S., Reyes-Sandoval, A., Cottingham, M. G., Ewer, K., Hill, A. V., Curr. Opin. Immunol. 2011, 23, 377-382.
5. Nabel, G. J., Designing tomorrow's vaccines. N. Engl. J. Med. 2013, 368, 551-560.
6. Xiang, Z. Q., Greenberg, L., Ertl, H. C., Rupprecht, C. E., Protection of non-human primates against rabies with an adenovirus recombinant vaccine. Virology 2014, 450-451, 243-249.
7. Brown, L. J., Rosatte, R. C., Fehlner-Gardiner, C., Ellison, J. A. et al., Oral vaccination and protection of striped skunks (Mephitis mephitis) against rabies using ONRAB˙. Vaccine 2014, 32, 3675-3679.
8. Shen, C. F., Lanthier, S., Jacob, D., Montes, J. et al., Process optimization for scale-up for rabies vaccine live adenovirus vector (AdRG1.3). Vaccine 2012, 30, 300-306.
9. Ondondo, B. O., The influence of delivery vectors on HIV vaccine efficiency. Frontiers in Microbiol. 2014, 5, 1-16.
10. Capone, S., D'Alise, A. M., Ammendola, V., Colloca, S. et al., Development of chimpanzee adenoviruses as vaccine vectors: Challenges and successes emerging from clinical trials. Expert Rev. Vaccines 2013, 13, 379-393.
11. Limbach, K. J., Richie, T. L., Viral vectors in malaria vaccine development. Parasite Immunol. 2009, 31, 501-519.
12. Li, S., Locke, E., Bruder, J., Clarke, D. et al., Viral vectors for malaria vaccine development. Vaccine 2007, 25, 2567-2574.
13. Shuldt, N. J., Amalfitano, A., Malaria vaccines: Focus on adenovirus based vectors. Vaccine 2012, 30, 5191-5198.
14. Swadling, L., Capone, S., Antrobus, R. D., Brown, A. et al., A human vaccine strategy based on chimpanzee adenoviral and MVA vectors that primes, boosts, and sustains functional HCV-specific T cell memory. Sci. Transl. Med. 2014, 6, 261ra153.
15. Tripp, R. A., Tompkins, M. S., Virus-vectored influenza virus vaccines. Viruses 2014, 6, 3055-3079.
16. Vemula, S. V., Mittal, S. K., Production of adenovirus vectors and their use as a delivery system for influenza vaccines. Expert Opin. Biol. Ther. 2010, 10, 1469-1487.
17. Tang, D. C., Zhang, J., Toro, H., Shi, Z., Van Kampen, K. R., Adenovirus as a carrier for the development of influenza virus-free avian influenza vaccines. Expert Rev. Vaccines 2009, 8, 469-481.
18. Majhen, D., Calderon, H., Chandra, N., Fajardo, C. A. et al., Adenovirus-based vaccines for fighting infectious diseases and cancer: Progress in the field. Human Gene Ther. 2014, 25, 301-317.
19. Cottingham, M. C., Carroll, M. W., Recombinant MVA vaccines: Dispelling the myths. Vaccine 2013, 31, 4247-4251.
20. Paoletti, E., Applications of pox virus vectors to vaccination: An update. Proc. Natl. Acad. Sci. U. S. A. 1996, 15, 11349-11353.
21. Tartaglia, J., Cox, W. I., Taylor, J., Perkus, M. et al., Highly attenuated poxvirus vectors. AIDS Res. Hum. Retroviruses 1992, 8, 1445-1447.
22. Jordan, I., Lohr, V., Genzel, Y., Reichl, U., Sandig, V., Elements in the development of a production process for modified Vaccinia virus Ankara. Microorganisms 2013, 1, 100-121.
23. Gilbert, C., Clinical development of modified Vaccinia virus Ankara vaccines. Vaccine 2013, 31, 4241-4246.
24. Subramanian, S., Kim, J. J., Harding, F., Altaras, G. M. et al., Scalable production of adenoviral vectors by transfection of adherent PER.C6 cells. Biotechnol. Prog. 2007, 23, 1210-1217.
25. Aurisicchio, L., Ciliberto, C. Genetic cancer vaccines: Current status and perspectives. Expert Opin. Ther. 2012, 12, 1043-1058.
26. Lusky, M., Good manufacturing practice production of adenoviral vectors for clinical trials. Hum. Gene Ther. 2005, 16, 281-291.
27. Grieger, J. C., Samulski, R. J., Adeno-associated virus vectorology, manufacturing, and clinical applications. Methods Enzymol. 2012, 507, 229-254.
28. Nehring, D., Gonzalez, R., Pörtner, R., Czermak, P., Experimental and modelling study of different process modes for retroviral production in a fixed bed reactor. J. Biotechnol. 2006, 122, 239-253.
29. Merten, O. W., Charrier, S., Laroudie, N., Fauchille, S. et al., Large-scale manufacture and characterization of a lentiviral vector produced for clinical ex vivo gene therapy application. Hum. Gene Ther. 2011, 22, 343-356.
30. Vellinga, J., Smith, P., Lipiec, A., Majhen, D. et al., Challenges in manufacturing adenoviral vectors for global vaccine product deployment. Hum. Gene Ther. 2014, 25, 318-327.
31. Silva, A. C., Fernandes, P., Sousa, M. F., Alves, P. M., Scalable production of adenovirus vectors. Methods Mol. Biol. 2014, 1089, 175-196.
32. Siegwart, P., Côté, J., Male, K., Luong, J. H. et al., Adaptive control at low glucose concentration of HEK-293 cell serum-free cultures. Biotechnol. Prog. 1999, 15, 608-616.
33. Garnier, A., Côté, J., Nadeau, I., Kamen, A., Massie, B., Scale-up of the adenovirus expression system for the production of recombinant protein in human 293S cells. Cytotechnol. 1994, 15, 145-155.
34. Iyer, P., Ostrove, J. M., Vacante, D., Comparison of manufacturing techniques for adenovirus production. Cytotechnol. 1999, 30, 169-172.
35. Xie, L., Metallo, C., Warren, J., Pilbrough, W. et al., Large-scale propagation of a replication-defective adenovirus vector in stirred-tank bioreactor PER.C6 cell culture under sparging conditions. Biotechnol. Bioeng. 2003, 83, 45-52.
36. Kamen, A., Henry, O., Development and optimization of an adenovirus production process. J. Gen. Med. 2004, 6, S184-S192.
37. Herk, H., Luitjens, A., Method for the production of ad26 adenoviral vectors. WO Patent 098592 A1, 2011.
38. Jordan, I., Vos, A., Beifuß, S., Neubert, A. et al., An avian cell line designed for production of highly attenuated viruses. Vaccine 2009, 27, 748-756.
39. Browne, S. W., Mehtali, M., The avian EB66˙ cell line, application to vaccines, and therapeutic protein production. PDA J. Pharm. Sci. Technol. 2010, 64, 419-425.
40. Kraus, B., von Fircks, S., Feigl, S., Koch, S. M. et al., Avian cell line - Technology for large scale vaccine production. BMC Proc. 2011, 5, P52.
41. Mayr, A., Genetically engineered virus for use in the propagation of preferential cells. US Patent 6682743 B2, 2004.
42. Jordan, I., Northoff, S., Thiele, M., Hartmann, S. et al., A chemically defined production process for highly attenuated poxviruses. Biologicals 2011, 39, 50-58.
43. Jordan, I., Woods, N., Whale, G., Sandig, V., Production of a viral-vectored vaccine candidate against tuberculosis. Bioprocess Int. 2012, 10, 46-55.
44. Djurup, R., Hensen, S. P., Purification of vaccinia virus- and recombinant vaccinia virus-based vaccines. US Patent 8415132 B2, 2013.
45. Merten, O. W., Schweizer, M., Chahal, P., Kamen, A., Production and purification of viral vectors and safety considerations to their use. Advanced Textbook on Gene Transfer, Gene Therapy and Genetic Pharmacology. 2014, pp. 493-515.
46. Morenweiser, R., Downstream processing of viral vectors and vaccines. Gene Ther. 2005, 12, S103-S110.
47. Segura, M. M., Kamen, A., Garnier, A., Overview of current scalable methods for purification of viral vectors, in: Merten, O. W., Al-Rubeai, M. (Eds.) Viral vectors for gene therapy: Methods and Protocols, Springer Science and Business media, New York, 2011, pp. 89-116.
48. Nestola, P., Silva, R. J. S., Peixoto, C., Alves, P. M. et al., Adenovirus purification by two-column, size exclusion simulated countercurrent chromatography. J. Chromatogr. A 2014, 1347, 111-121.
49. Peixoto, C., Ferreira, T. B., Sousa, M. F. Q., Carrondo, M. J. T., Alves, P. M., Towards purification of adenoviral vectors based on membrane technology. Biotechnol. Prog. 2008, 24, 1290-1296.
50. Nestola, P., Villain, L., Peixoto, C., Martins, D. L. et al., Impact of grafting on the design of new membrane adsorbers for adenovirus purification. J. Biotechnol. 2014, 181, 1-11.
51. Xiong, Y., Methods using ion exchange and gel filtration chromatography for poxvirus purification. WO Patent 100521 A1, 2009.
52. Wolf, M. A., Siewert, C., Hansen, S. P., Faber, R., Reichl, U., Purification of cell culture-derived modified Vaccinia Ankara Virus by pseudo-affinity membrane adsorbers and hydrophobic interaction chromatography. Biotechnol. Bioeng. 2010, 107, 312-320.
53. Wolf, M. W., Siewert, C., Lehmann, S., Hansen, S. P. et al., Capturing of cell culture derived modified Vaccinia Ankara virus by ion exchange and pseudo-affinity membrane adsorbers. Biotechnol. Bioeng. 2010, 105, 761-769.
54. Hensen, S. P., Faber, R., Reichl, U., Wolf, M., Gram, A. P., Purification of vaccinia viruses using hydrophobic interaction chromatography. US Patent 8470578 B2, 2013.
55. Aucoin, M. G., Perrier, M., Kamen, A. A., Critical assessment of current adeno-associated viral vector production and quantification methods. Biotechnol. Adv. 2008, 26, 73-88.
56. Kamen, A. A., Aucoin, M. G., Merten, O. W., Alves, P. et al., An initiative tomanufacture and characterize baculovirus reference material. J. Invertebr. Pathol. 2011, 107, S113-S117.
57. Roitsch, C., Achstetter, T., Benchaibi, M., Bonfils, E. et al., Characterization and quality control of recombinant adenovirus vectors for gene therapy. J. Chromatogr. B Biomed. Sci. Appl. 2001, 10, 263-280.
58. Hutchins, B., Sajjadi, N., Seaver, S., Shepherd, A., Bauer, S. R. et al., Working toward an adenoviral testing standard. Mol. Ther. 2000, 2, 532-534.