Identification and optimization of critical process parameters for the production of NOMV vaccine against Neisseria meningitidis

Vaccine

Volumn 30, Issue 24, 2012, Pages 3683-3690

  van de Waterbeemd, Bas ^a   Streefland, Mathieu ^b   van Keulen, Lonneke ^a   van den IJssel, Jan ^a   de Haan, Alex ^a   Eppink, Michel H ^b   van der Pol, Leo A ^a  

^a NATIONAL INSTITUTE FOR PUBLIC HEALTH AND THE ENVIRONMENT   (Netherlands)

^b WAGENINGEN UNIVERSITY   (Netherlands)

Author keywords

EDTA extraction; Harvest; Neisseria meningitidis; OMV production; Optimization; QbD (Quality by Design)

Indexed keywords

BACTERIAL VACCINE; EDETIC ACID; NATIVE OUTER MEMBRANE VESICLE VACCINE; UNCLASSIFIED DRUG;

ARTICLE; BACTERIOLYSIS; DRUG QUALITY; IMMUNOGENICITY; NEISSERIA MENINGITIDIS; NONHUMAN; PH; PRIORITY JOURNAL;

BIOTECHNOLOGY; CHEMICAL FRACTIONATION; EDETIC ACID; EXOSOMES; HUMANS; MENINGOCOCCAL INFECTIONS; MENINGOCOCCAL VACCINES; NEISSERIA MENINGITIDIS, SEROGROUP B; TECHNOLOGY, PHARMACEUTICAL;

EID: 84861011410     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.03.028     Document Type: Article

References (62)

1. Girard M.P., Preziosi M.P., Aguado M.T., Kieny M.P. A review of vaccine research and development: meningococcal disease. Vaccine 2006, 24(May (22)):4692-4700.
2. Holst J., Martin D., Arnold R., Huergo C.C., Oster P., O'Hallahan J., et al. Properties and clinical performance of vaccines containing outer membrane vesicles from Neisseria meningitidis. Vaccine 2009, 27(June (Suppl. 2)):B3-B12.
3. Jodar L., Feavers I.M., Salisbury D., Granoff D.M. Development of vaccines against meningococcal disease. Lancet 2002, 359(April (9316)):1499-1508.
4. Lewis S., Sadarangani M., Hoe J.C., Pollard A.J. Challenges and progress in the development of a serogroup B meningococcal vaccine. Expert Rev Vaccines 2009, 8(June (6)):729-745.
5. Deatherage B.L., Lara J.C., Bergsbaken T., Barrett S.L., Lara S., Cookson B.T. Biogenesis of bacterial membrane vesicles. Mol Microbiol 2009.
6. Saukkonen K., Leinonen M., Abdillahi H., Poolman J.T. Comparative evaluation of potential components for group B meningococcal vaccine by passive protection in the infant rat and in vitro bactericidal assay. Vaccine 1989, 7(August (4)):325-328.
7. Martin D.R., Ruijne N., McCallum L., O'Hallahan J., Oster P. The VR2 epitope on the PorA P1. 7-2,4 protein is the major target for the immune response elicited by the strain-specific group B meningococcal vaccine MeNZB. Clin Vaccine Immunol 2006, 13(April (4)):486-491.
8. Thornton V., Lennon D., Rasanathan K., O'Hallahan J., Oster P., Stewart J., et al. Safety and immunogenicity of New Zealand strain meningococcal serogroup B OMV vaccine in healthy adults: beginning of epidemic control. Vaccine 2006, 24(February (9)):1395-1400.
9. Martin D.R., Walker S.J., Baker M.G., Lennon D.R. New Zealand epidemic of meningococcal disease identified by a strain with phenotype B:4:P1.4. J Infect Dis 1998, 177(February (2)):497-500.
10. Sierra G.V., Campa H.C., Varcacel N.M., Garcia I.L., Izquierdo P.L., Sotolongo P.F., et al. Vaccine against group B Neisseria meningitidis: protection trial and mass vaccination results in Cuba. NIPH Ann 1991, 14(December (2)):195-207. [discussion 8-10].
11. Fredriksen J.H., Rosenqvist E., Wedege E., Bryn K., Bjune G., Froholm L.O., et al. Production, characterization and control of MenB-vaccine Folkehelsa: an outer membrane vesicle vaccine against group B meningococcal disease. NIPH Ann 1991, 14(December (2)):67-79. [discussion-80].
12. van der Ley P., Steeghs L., Hamstra H.J., ten Hove J., Zomer B., van Alphen L. Modification of lipid A biosynthesis in Neisseria meningitidis lpxL mutants: influence on lipopolysaccharide structure, toxicity, and adjuvant activity. Infect Immun 2001, 69(October (10)):5981-5990.
13. Keiser P.B., Biggs-Cicatelli S., Moran E.E., Schmiel D.H., Pinto V.B., Burden R.E., et al. A phase 1 study of a meningococcal native outer membrane vesicle vaccine made from a group B strain with deleted lpxL1 and synX, over-expressed factor H binding protein, two PorAs and stabilized OpcA expression. Vaccine 2010.
14. Fisseha M., Chen P., Brandt B., Kijek T., Moran E., Zollinger W. Characterization of native outer membrane vesicles from lpxL mutant strains of Neisseria meningitidis for use in parenteral vaccination. Infect Immun 2005, 73(July (7)):4070-4080.
15. van de Waterbeemd B., Streefland M., van der Ley P., Zomer B., van Dijken H., Martens D., et al. Improved OMV vaccine against Neisseria meningitidis using genetically engineered strains and a detergent-free purification process. Vaccine 2010, 28(July (30)):4810-4816.
16. Koeberling O., Seubert A., Granoff D.M. Bactericidal antibody responses elicited by a meningococcal outer membrane vesicle vaccine with overexpressed factor H-binding protein and genetically attenuated endotoxin. J Infect Dis 2008, 198(July (2)):262-270.
17. Koeberling O., Giuntini S., Seubert A., Granoff D.M. Meningococcal OMV vaccines from mutant strains engineered to express factor H binding proteins from antigenic variant groups 1 and 2. Clin Vaccine Immunol 2008.
18. Kovacs-Simon A., Titball R.W., Michell S.L. Lipoproteins of bacterial pathogens. Infect Immun 2010.
19. Post D.M., Zhang D., Eastvold J.S., Teghanemt A., Gibson B.W., Weiss J.P. Biochemical and functional characterization of membrane blebs purified from Neisseria meningitidis serogroup B. J Biol Chem 2005, 280(November (46)):38383-38394.
20. Hoekstra D., van der Laan J.W., de Leij L., Witholt B. Release of outer membrane fragments from normally growing Escherichia coli. Biochim Biophys Acta 1976, 455(December (3)):889-899.
21. Devoe I.W., Gilchrist J.E. Release of endotoxin in the form of cell wall blebs during in vitro growth of Neisseria meningitidis. J Exp Med 1973, 138(November (5)):1156-1167.
22. Grizot S., Buchanan S.K. Structure of the OmpA-like domain of RmpM from Neisseria meningitidis. Mol Microbiol 2004, 51(February (4)):1027-1037.
23. Klugman K.P., Gotschlich E.C., Blake M.S. Sequence of the structural gene (rmpM) for the class 4 outer membrane protein of Neisseria meningitidis, homology of the protein to gonococcal protein III and Escherichia coli OmpA, and construction of meningococcal strains that lack class 4 protein. Infect Immun 1989, 57(July (7)):2066-2071.
24. Ferrari G., Garaguso I., Adu-Bobie J., Doro F., Taddei A.R., Biolchi A., et al. Outer membrane vesicles from group B Neisseria meningitidis delta gna33 mutant: proteomic and immunological comparison with detergent-derived outer membrane vesicles. Proteomics 2006, 6(March (6)):1856-1866.
25. Prachayasittikul V., Isarankura-Na-Ayudhya C., Tantimongcolwat T., Nantasenamat C., Galla H.J. EDTA-induced membrane fluidization and destabilization: biophysical studies on artificial lipid membranes. Acta Biochim Biophys Sin (Shanghai) 2007, 39(November (11)):901-913.
26. Haque H., Russell A.D. Effect of chelating agents on the susceptibility of some strains of gram-negative bacteria to some antibacterial agents. Antimicrobial Agents Chemother 1974, 6(August (2)):200-206.
27. Haque H., Russell A.D. Effect of ethylenediaminetetraacetic acid and related chelating agents on whole cells of gram-negative bacteria. Antimicrobial Agents Chemother 1974, 5(May (5)):447-452.
28. Zollinger W.D., Kasper D.L., Veltri B.J., Artenstein M.S. Isolation and characterization of a native cell wall complex from Neisseria meningitidis. Infect Immun 1972, 6(November (5)):835-851.
29. Drabick J.J., Brandt B.L., Moran E.E., Saunders N.B., Shoemaker D.R., Zollinger W.D. Safety and immunogenicity testing of an intranasal group B meningococcal native outer membrane vesicle vaccine in healthy volunteers. Vaccine 1999, 18(August (1-2)):160-172.
30. Katial R.K., Brandt B.L., Moran E.E., Marks S., Agnello V., Zollinger W.D. Immunogenicity and safety testing of a group B intranasal meningococcal native outer membrane vesicle vaccine. Infect Immun 2002, 70(February (2)):702-707.
31. Guthrie T., Wong S.Y., Liang B., Hyland L., Hou S., Hoiby E.A., et al. Local and systemic antibody responses in mice immunized intranasally with native and detergent-extracted outer membrane vesicles from Neisseria meningitidis. Infect Immun 2004, 72(May (5)):2528-2537.
32. Keiser P.B., Gibbs B.T., Coster T.S., Moran E.E., Stoddard M.B., Labrie J.E., et al. A phase 1 study of a group B meningococcal native outer membrane vesicle vaccine made from a strain with deleted lpxL2 and synX and stable expression of opcA. Vaccine 2010.
33. van der Ley P., van den Dobbelsteen G. Next-generation outer membrane vesicle vaccines against Neisseria meningitidis based on nontoxic LPS mutants. Hum Vaccines 2011, 7(August (8)).
34. Perez-Pardo MA, Ali S, Balasundaram B, Mannall GJ, Baganz F, Bracewell DG. Assessment of the manufacturability of Escherichia coli high cell density fermentations. Biotechnol Progr 2011; May 2.
35. Frasch C.E., Van Alphen L., Holst J., Poolman J., Rosenqvist E. Meningococcal vaccines, methods and protocols 2001, Humana Press Inc., Totowa, NJ, p. 81-107.
36. ICH International Conference on Harmonisation; guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products. Notice. Food and Drug Administration, HHS. Fed Regist 1999, 64(August (159)):44928-44935.
37. Rathore A.S., Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol 2009, 27(January (1)):26-34.
38. ICH International Conference on Harmonisation; guidance on Q8(R1) pharmaceutical development; addition of annex; availability. Notice. Fed Regist 2009, 74(June (109)):27325-27326.
39. Rathore A.S. Roadmap for implementation of quality by design (QbD) for biotechnology products. Trends Biotechnol 2009, 27(September (9)):546-553.
40. Baart G.J., Willemsen M., Khatami E., de Haan A., Zomer B., Beuvery E.C., et al. Modeling Neisseria meningitidis B metabolism at different specific growth rates. Biotechnol Bioeng 2008, 101(December (5)):1022-1035.
41. Gaines Das R.E., Brugger P., Patel M., Mistry Y., Poole S. Monocyte activation test for pro-inflammatory and pyrogenic contaminants of parenteral drugs: test design and data analysis. J Immunol Methods 2004, 288(May (1-2)):165-177.
42. Borrow R., Balmer P., Miller E. Meningococcal surrogates of protection-serum bactericidal antibody activity. Vaccine 2005, 23(March (17-18)):2222-2227.
43. Holst J., Feiring B., Fuglesang J.E., Hoiby E.A., Nokleby H., Aaberge I.S., et al. Serum bactericidal activity correlates with the vaccine efficacy of outer membrane vesicle vaccines against Neisseria meningitidis serogroup B disease. Vaccine 2003, 21(January (7-8)):734-737.
44. Holten E. Serotypes of Neisseria meningitidis isolated from patients in Norway during the first six months of 1978. J Clin Microbiol 1979, 9(February (2)):186-188.
45. van der Ley P., van der Biezen J., Poolman J.T. Construction of Neisseria meningitidis strains carrying multiple chromosomal copies of the porA gene for use in the production of a multivalent outer membrane vesicle vaccine. Vaccine 1995, 13(March (4)):401-407.
46. Baart G.J., de Jong G., Philippi M., van't Riet K., van der Pol L.A., Beuvery E.C., et al. Scale-up for bulk production of vaccine against meningococcal disease. Vaccine 2007, 25(August (34)):6399-6408.
47. Lugtenberg B., Meijers J., Peters R., van der Hoek P., van Alphen L. Electrophoretic resolution of the major outer membrane protein of Escherichia coli K12 into four bands. FEBS Lett 1975, 58(October (1)):254-258.
48. van den Dobbelsteen G.P., van Dijken H.H., Pillai S., van Alphen L. Immunogenicity of a combination vaccine containing pneumococcal conjugates and meningococcal PorA OMVs. Vaccine 2007, 25(March (13)):2491-2496.
49. Luijkx T., van Dijken H., van Els C., van den Dobbelsteen G. Heterologous prime-boost strategy to overcome weak immunogenicity of two serosubtypes in hexavalent Neisseria meningitidis outer membrane vesicle vaccine. Vaccine 2006, 24(March (10)):1569-1577.
50. de Kleijn E., van Eijndhoven L., Vermont C., Kuipers B., van Dijken H., Rumke H., et al. Serum bactericidal activity and isotype distribution of antibodies in toddlers and schoolchildren after vaccination with RIVM hexavalent PorA vesicle vaccine. Vaccine 2001, 20(November (3-4)):352-358.
51. Saunders N.B., Shoemaker D.R., Brandt B.L., Moran E.E., Larsen T., Zollinger W.D. Immunogenicity of intranasally administered meningococcal native outer membrane vesicles in mice. Infect Immun 1999, 67(January (1)):113-119.
52. Zollinger W.D., Donets M.A., Schmiel D.H., Pinto V.B., Labrie J., Moran E.E., et al. Design and evaluation in mice of a broadly protective meningococcal group B native outer membrane vesicle vaccine. Vaccine 2010.
53. Katsui N., Tsuchido T., Hiramatsu R., Fujikawa S., Takano M., Shibasaki I. Heat-induced blebbing and vesiculation of the outer membrane of Escherichia coli. J Bacteriol 1982, 151(September (3)):1523-1531.
54. Vasilyeva N.V., Tsfasman I.M., Suzina N.E., Stepnaya O.A., Kulaev I.S. Outer membrane vesicles of Lysobacter sp. Doklady 2009, 426:139-142.
55. McBroom A.J., Kuehn M.J. Release of outer membrane vesicles by Gram-negative bacteria is a novel envelope stress response. Mol Microbiol 2007, 63(January (2)):545-558.
56. Bishop D.G., Work E. An extracellular glycolipid produced by Escherichia coli grown under lysine-limiting conditions. Biochem J 1965, 96(August (2)):567-576.
57. Rothfield L., Pearlman-Kothencz M. Synthesis and assembly of bacterial membrane components. A lipopolysaccharide-phospholipid-protein complex excreted by living bacteria. J Mol Biol 1969, 44(September (3)):477-492.
58. Claassen I., Meylis J., van der Ley P., Peeters C., Brons H., Robert J., et al. Production, characterization and control of a Neisseria meningitidis hexavalent class 1 outer membrane protein containing vesicle vaccine. Vaccine 1996, 14(July (10)):1001-1008.
59. Gorringe A, Vincent P, Halliwell D, Reddin K. Patent WO2006/008504 A1: Stable compositions containing outer membrane vesicles, methods of manufacturing; 2006.
60. Arigita C., Jiskoot W., Westdijk J., van Ingen C., Hennink W.E., Crommelin D.J., et al. Stability of mono- and trivalent meningococcal outer membrane vesicle vaccines. Vaccine 2004, 22(January (5-6)):629-642.
61. Eglon M.N., Duffy A.M., O'Brien T., Strappe P.M. Purification of adenoviral vectors by combined anion exchange and gel filtration chromatography. J Gene Med 2009, 11(November (11)):978-989.
62. Tin Lee C., Morreale G., Middelberg A.P. Combined in-fermenter extraction and cross-flow microfiltration for improved inclusion body processing. Biotechnol Bioeng 2004, 85(January (1)):103-113.