Production of a viral-vectored vaccine candidate against tuberculosis

BioProcess International

Volumn 10, Issue 8, 2012, Pages 46-56

  Jordan, Ingo ^a   Woods, Nigel ^b   Whale, Gary ^b   Sandig, Volker ^a  

^a PROBIOGEN AG   (Germany)

^b Emergent Biosolutions   (United Kingdom)

Author keywords

Cell culture; Cell line development; Downstream processing; Fed batch; Filtration; Scale up

Indexed keywords

BCG VACCINE; ROTAVIRUS VACCINE; SMALLPOX VACCINE; VIRUS VECTOR; WART VIRUS VACCINE;

ARTICLE; CELL PROLIFERATION; CELLULAR IMMUNITY; DNA VIRUS; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG MANUFACTURE; EPIDEMIOLOGY; FED BATCH CULTURE; HEALTH CARE COST; HEALTH PROGRAM; HUMAN; HUMAN ADENOVIRUS 5; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE SYSTEM; MALNUTRITION; MULTIDRUG RESISTANCE; MYCOBACTERIUM TUBERCULOSIS; NONHUMAN; PANDEMIC INFLUENZA; PROCESS DEVELOPMENT; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SCALE UP; SEASONAL INFLUENZA; SOCIOECONOMICS; TRANSMISSION ELECTRON MICROSCOPY; TUBERCULOSIS; VACCINATION; VIRUS PARTICLE; VIRUS REPLICATION;

EID: 84868636483     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (45)

1. Zurbriggen S, et al. Isolation of Sabin-Like Polioviruses from Wastewater in a Country Using Inactivated Polio Vaccine. Appl. Environ. Microbiol. 74(18) 2008: 5608-5614.
2. Vora S, et al. Severe Eczema Vaccinatum in a Household Contact of a Smallpox Vaccinee. Clin. Infect. Dis. 46(10) 2008: 1555-1561. (Pubitemid 351706737)
3. Fulginiti VA, et al. Smallpox Vaccination: A Review, Part 2 - Adverse Events. Clin. Infect. Dis. 37(2) 2003: 251-271. (Pubitemid 36930357)
4. Parrino J, Graham BS. Smallpox Vaccines: Past, Present, and Future. J. Allergy Clin. Immunol. 118(6) 2006: 1320-1326. (Pubitemid 44854134)
5. Hayden EC. Biodefence Since 9/11: The Price of Protection. Nature 477(7363) 2011: 150-152.
6. Kemper AR, Davis MM, Freed GL. Expected Adverse Events in a Mass Smallpox Vaccination Campaign. Eff. Clin. Pract. 5(2) 2002: 84-90.
7. Plotkin SA. Vaccines: The Fourth Century. Clin. Vaccine Immunol. 16(12) 2009: 1709-1719.
8. Hawkridge T, et al. Safety and Immunogenicity of a New Tuberculosis Vaccine, MVA85A, in Healthy Adults in South Africa. J. Infect. Dis. 198(4) 2008: 544-552.
9. Cebere I, et al. Phase 1 Clinical Trial Safety of DNA- and Modified Virus Ankara-Vectored Human Immunodeficiency Virus Type 1 (HIV-1) Vaccines Administered Alone and in a Prime-Boost Regime to Healthy HIV-1-Uninfected Volunteers. Vaccine 24(4) 2006: 417-425. (Pubitemid 41832544)
10. Dorrell L, et al. Safety and Tolerability of Recombinant Modified Vaccinia Virus Ankara Expressing an HIV-1 Gag/Multiepitope Immunogen (MVA.HIVA) in HIV-1-Infected Persons Receiving Combination Antiretroviral Therapy. Vaccine 25(17) 2007: 3277-3283. (Pubitemid 46527996)
11. Webster DP, et al. Enhanced T Cell-Mediated Protection Against Malaria in Human Challenges By Using the Recombinant Poxviruses FP9 and Modified Vaccinia Virus Ankara. Proc. Natl. Acad. Sci. USA 102(13)
12. McShane H. Tuberculosis Vaccines: Beyond Bacille Calmette-Guerin. Philos. Trans. Roy. Soc. Lond. B Biol. Sci. 366(1579) 2011: 2782-2789.
13. Taylor J, et al. Biological and Immunogenic Properties of a Canarypox-Rabies Recombinant, ALVAC-RG (vCP65) in Non-Avian Species. Vaccine 13(6) 1995: 539-549.
14. Drexler I, et al. Highly Attenuated Modified Vaccinia Virus Ankara Replicates in Baby Hamster Kidney Cells, a Potential Host for Virus Propagation, but Not in Various Human Transformed and Primary Cells. J. Gen. Virol. 79 (Pt 2) 1998: 347-352. (Pubitemid 28048439)
15. Jordan I, et al. Cell Lines from the Egyptian Fruit Bat Are Permissive for Modified Vaccinia Ankara. Virus Res. 145(1) 2009: 54-62.
16. Sutter G, Moss B. Nonreplicating Vaccinia Vector Efficiently Expresses Recombinant Genes. Proc. Natl. Acad. Sci. USA 89(22) 1992: 10847-10851.
17. Sutter G, et al. A Recombinant Vector Derived from the Host Range-Restricted and Highly Attenuated MVA Strain of Vaccinia Virus Stimulates Protective Immunity in Mice to Influenza Virus. Vaccine 12(11) 1994: 1032-1040. (Pubitemid 24246876)
18. Liu L, Chavan R, Feinberg MB. Dendritic Cells Are Preferentially Targeted Among Hematolymphocytes by Modified Vaccinia Virus Ankara and Play a Key Role in the Induction of Virus-Specific T Cell Responses In Vivo. BMC Immunol. 9, 2008: 15.
19. McShane H, et al. Protective Immunity Against Mycobacterium tuberculosis Induced By Dendritic Cells Pulsed with Both CD8(+)- and CD4(+)-T-Cell Epitopes from Antigen 85A. Infect. Immun. 70(3) 2002: 1623-1626. (Pubitemid 34163445)
20. WHO Report 2011 on Global Tuberculosis Control. World Health Organization: Geneva, Switzerland, 2011; www.who.int/tb/publications/global- report/en.
21. Haydel SE. Extensively Drug-Resistant Tuberculosis: A Sign of the Times and an Impetus for Antimicrobial Discovery. Pharmaceut. (Basel) 3(7) 2010: 2268-2290.
22. Velayati AA, et al. Emergence of New Forms of Totally Drug-Resistant Tuberculosis Bacilli: Super Extensively Drug-Resistant Tuberculosis or Totally Drug-Resistant Strains in Iran. Chest 136(2) 2009: 420-425.
23. Udwadia ZF, et al. Totally Drug-Resistant Tuberculosis in India. Clin. Infect. Dis. 2011.
24. Abu-Raddad LJ, et al. Epidemiological Benefits of More-Effective Tuberculosis Vaccines, Drugs, and Diagnostics. Proc. Natl. Acad. Sci. USA 106(33) 2009: 13980-13985.
25. Thaiss CA, Kaufmann SH. Toward Novel Vaccines Against Tuberculosis: Current Hopes and Obstacles. Yale J. Biol. Med. 83(4) 2010: 209-215.
26. Horwitz MA, et al. Protective Immunity Against Tuberculosis Induced By Vaccination with Major Extracellular Proteins of Mycobacterium tuberculosis. Proc. Natl. Acad. Sci. USA 92(5) 1995: 1530-1534.
27. Launois P, et al. T-Cell-Epitope Mapping of the Major Secreted Mycobacterial Antigen Ag85A in Tuberculosis and Leprosy. Infect. Immun. 62(9) 1994: 3679-3687.
28. Huygen K, et al. Mapping of TH1 Helper T-Cell Epitopes on Major Secreted Mycobacterial Antigen 85A in Mice Infected with Live Mycobacterium bovis BCG. Infect. Immun. 62(2) 1994: 363-370. (Pubitemid 24033750)
29. Gilbert SC, et al. Synergistic DNA-MVA Prime-Boost Vaccination Regimes for Malaria and Tuberculosis. Vaccine 24(21) 2006: 4554-4561. (Pubitemid 43776762)
30. Coulibaly S, et al. The Nonreplicating Smallpox Candidate Vaccines Defective Vaccinia Lister (dVV-L) and Modified Vaccinia Ankara (MVA) Elicit Robust Long-Term Protection. Virology 341(1) 2005: 91-101. (Pubitemid 41356718)
31. Rotz LD, et al. Vaccinia (Smallpox) Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2001. MMWR Recomm. Rep. 50(RR-10) 2001: 1-25; quiz CE21-27.
32. Chua JV, Chen WH. Bench-to-Bedside Review: Vaccine Protection Strategies During Pandemic Flu Outbreaks. Crit. Care. 14(2) 2010: 218.
33. Monto AS, Maassab HF, Bryan ER. Relative Efficacy of Embryonated Eggs and Cell Culture for Isolation of Contemporary Influenza Viruses. J. Clin. Microbiol. 13(1) 1981: 233-235. (Pubitemid 11176698)
34. White DO, Fazekas De St Groth S. Variation of Host Resistance to Influenza Viruses in the Allantois. J. Hyg. (London) 57(1) 1959: 123-133.
35. Philipp HC, Kolla I. Laboratory Host Systems for Extraneous Agent Testing in Avian Live Virus Vaccines: Problems Encountered. Biologicals 38(3) 2010: 350-351.
36. Enserink M. Influenza: Crisis Underscores Fragility of Vaccine Production System. Science 306(5695) 2004: 385. (Pubitemid 39372410)
37. Weissmahr RN, Schupbach J, Boni J. Reverse Transcriptase Activity in Chicken Embryo Fibroblast Culture Supernatants Is Associated with Particles Containing Endogenous Avian Retrovirus EAV-0 RNA. J. Virol. 71(4) 1997: 3005-3012. (Pubitemid 27119944)
38. Jordan I, et al. An Avian Cell Line Designed for Production of Highly Attenuated Viruses. Vaccine 27(5) 2009: 748-756.
39. Lohr V, et al. New Avian Suspension Cell Lines Provide Production of Influenza Virus and MVA in Serum-Free Media: Studies on Growth, Metabolism, and Virus Propagation. Vaccine 27(36) 2009: 4975-4982.
40. Rietdorf J, et al. Kinesin-Dependent Movement on Microtubules Precedes Actin-Based Motility of Vaccinia Virus. Nat. Cell. Biol. 3(11) 2001: 992-1000. (Pubitemid 34428744)
41. Boulanger D, Smith T, Skinner MA. Morphogenesis and Release of Fowlpox Virus. J. Gen. Virol. 81(Pt 3) 2000: 675-687. (Pubitemid 30105497)
42. Cyrklaff M, et al. Cryo-Clectron Tomography of Vaccinia Virus. Proc. Natl. Acad. Sci. USA 102(8) 2005: 2772-2777.
43. Meiser A, et al. Comparison of Virus Production in Chicken Embryo Fibroblasts Infected with the WR, IHD-J and MVA Strains of Vaccinia Virus: IHD-J Is Most Efficient in Trans-Golgi Network Wrapping and Extracellular Enveloped Virus Release. J. Gen. Virol. 84(Pt 6) 2003: 1383-1392. (Pubitemid 36675506)
44. CBER. Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications. US Food and Drug Administration: Rockville, MD, February 2010.
45. EMA/CHMP/VWP/141697/2009. Guideline on Quality, Non-Clinical and Clinical Aspects of Live Recombinant Viral Vectored Vaccines. Committee for Medicinal Product for Human Use: Brussels, Belgium, 24