Gene-expression-based quality scores indicate optimal harvest point in Bordetella pertussis cultivation for vaccine production

Biotechnology and Bioengineering

Volumn 103, Issue 5, 2009, Pages 900-908

  Van De Waterbeemd, Bas ^a   Streefland, Mathieu ^a   Pennings, Jeroen ^b   Van Der Pol, Leo ^a   Beuvery, Coen ^c   Tramper, Johannes ^d   Martens, Dirk ^d  

^a NETHERLANDS VACCINE INSTITUTE   (Netherlands)

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

^c PAT Consultancy ^*  (Netherlands)

^d WAGENINGEN UNIVERSITY   (Netherlands)

Author keywords

Batch cultivation; Bordetella pertussis; Harvest point; Microarray; Process development; Product quality; Transcriptome; Vaccine

Indexed keywords

BATCH CULTIVATION; BORDETELLA PERTUSSIS; HARVEST POINT; PROCESS DEVELOPMENT; PRODUCT QUALITY; TRANSCRIPTOME;

CHROMATOGRAPHIC ANALYSIS; GENES; HARVESTING; OPTIMIZATION; VACCINES;

QUALITY CONTROL;

GLUTAMIC ACID; LACTIC ACID; MESSENGER RNA; VACCINE;

ARTICLE; BACTERIAL GROWTH; BORDETELLA PERTUSSIS; DNA MICROARRAY; GENE EXPRESSION; GOLD STANDARD; GROWTH CURVE; NONHUMAN; PROCESS DEVELOPMENT; VACCINE PRODUCTION; VIRULENCE;

ANTIGENS, BACTERIAL; BORDETELLA PERTUSSIS; CULTURE MEDIA; GENE EXPRESSION PROFILING; GLUTAMIC ACID; INDUSTRIAL MICROBIOLOGY; LACTIC ACID; PERTUSSIS VACCINE; QUALITY ASSURANCE, HEALTH CARE; TIME FACTORS; VIRULENCE FACTORS;

BORDETELLA PERTUSSIS;

EID: 67650793189     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22326     Document Type: Article

References (34)

1. Arnold SA, Gaensakoo R, Harvey LM, McNeil B. 2002. Use of at-line and insitu near-infrared spectroscopy to monitor biomass in an industrial fed-batch Escherichia coli process. Biotechnol Bioeng 80(4):405-413. (Pubitemid 35230934)
2. Bellalou J, Relyveld EH. 1984. Studies on culture conditions of Bordetella pertussis and relationship to immunogenicity of vaccines. Ann Microbiol (Paris) 135(1):101-110. (Pubitemid 14071991)
3. Blencke HM, Homuth G, Ludwig H, Mader U, Hecker M, Stulke J. 2003. Transcriptional profiling of gene expression in response to glucose in Bacillus subtilis: Regulation of the central metabolic pathways. Metab Eng 5(2):133-149. (Pubitemid 36837556)
4. Cogdill R, Drennen J. 2008. Risk-based quality by design (QbD): A Taguchi perspective on the assessment of product quality, and the quantitative linkage of drug product parameters and clinical performance. J Pharm Innov 3(1):23-29.
5. Corbel MJ, Xing DK. 2004. Toxicity and potency evaluation of pertussis vaccines. Expert Rev Vaccines 3(1):89-101.
6. Cummings CA, Bootsma HJ, Relman DA, Miller JF. 2006. Species- and strain-specific control of a complex, flexible regulon by Bordetella BvgAS. J Bacteriol 188(5):1775-1785.
7. Elias DA, Tollaksen SL, Kennedy DW, Mottaz HM, Giometti CS, McLean JS, Hill EA, Pinchuk GE, Lipton MS, Fredrickson JK. 2007. The influence of cultivation methods on Shewanella oneidensis physiology and proteome expression. Arch Microbiol 189(4):313-324.
8. FDA. 2004. Guidance for Industry, PAT-A framework for innovative pharmaceutical development, manufacturing and quality assurance. Pharmaceutical CGMP's.
9. Ferreira AP, Alves TP, Menezes JC. 2005. Monitoring complex media fermentations with near-infrared spectroscopy: Comparison of different variable selection methods. Biotechnol Bioeng 91(4):474-481.
10. Gnoth S, Jenzsch M, Simutis R, Lubbert A. 2007. Process analytical technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control. J Biotechnol 132(2):180-186. (Pubitemid 47599702)
11. Gupta P, Lee KH. 2007. Genomics and proteomics in process development: Opportunities and challenges. Trends Biotechnol 25(7):324-330. (Pubitemid 46899244)
12. Hamstra HJ, Kuipers B, Schijf-Evers D, Loggen HG, Poolman JT. 1995. The purification and protective capacity of Bordetella pertussis outer membrane proteins. Vaccine 13(8):747-752.
13. Irwin JO, Standfast AF. 1957. The intracerebral mouse-protection test for pertussis vaccines. J Hyg (Lond) 55(1):50-80.
14. Kasahara T, Miyazaki T, Nitta H, Ono A, Miyagishima T, Nagao T, Urushidani T. 2006. Evaluation of methods for duration of preservation of RNA quality in rat liver used for transcriptome analysis. J Toxicol Sci 31(5):509-519. (Pubitemid 46045158)
15. Kendrick PL, Eldering G, Dixon MK, Misner J. 1947. Mouse protection tests in the study of Pertussis vaccine: A comparative series using the intracerebral route for challenge. Am J Public Health Nations Health 37(7):803-810.
16. Kinnear SM, Marques RR, Carbonetti NH. 2001. Differential regulation of Bvg-activated virulence factors plays a role in Bordetella pertussis pathogenicity. Infect Immun 69(4):1983-1993.
17. Kredich NM. 1971. Regulation of L-cysteine biosynthesis in Salmonella typhimurium. I. Effects of growth of varying sulfur sources and Oacetyl- L-serine on gene expression. J Biol Chem 246(11):3474-3484.
18. Mills KH. 2001. Immunity to Bordetella pertussis. Microbes Infect 3(8): 655-677.
19. Mutter GL, Zahrieh D, Liu C, Neuberg D, Finkelstein D, Baker HE, Warrington JA. 2004. Comparison of frozen and RNALater solid tissue storage methods for use in RNA expression microarrays. BMC Genomics 5(1):88. (Pubitemid 39546637)
20. Nakamura MM, Liew SY, Cummings CA, Brinig MM, Dieterich C, Relman DA. 2006. Growth phase- and nutrient limitation-associated transcript abundance regulation in Bordetella pertussis. Infect Immun 74(10): 5537-5548. (Pubitemid 44484537)
21. Nakao M, Bono H, Kawashima S, Kamiya T, Sato K, Goto S, Kanehisa M. 1999. Genome-scale gene expression analysis and pathway reconstruction in KEGG. Genome Inform Ser Workshop Genome Inform 10:94-103.
22. Nystrom T. 2004. Stationary-phase physiology. Annu Rev Microbiol 58: 161-181.
23. Ogata H, Goto S, Sato K, Fujibuchi W, Bono H, Kanehisa M. 1999. KEGG: Kyoto Encyclopedia of Genes and Genomes. Nucleic Acids Res 27(1): 29-34. (Pubitemid 29209394)
24. Parkhill J, Sebaihia M, Preston A, Murphy LD, Thomson N, Harris DE, Holden MT, Churcher CM, Bentley SD, Mungall KL, et al. 2003. Comparative analysis of the genome sequences of Bordetella pertussis, Bordetella parapertussis and Bordetella bronchiseptica. Nat Genet 35(1):32-40. (Pubitemid 37048593)
25. Quackenbush J. 2001. Computational analysis of microarray data. Nat Rev Genet 2(6):418-427.
26. Ramalho AS, Beck S, Farinha CM, Clarke LA, Heda GD, Steiner B, Sanz J, Gallati S, Amaral MD, Harris A, Tzetis M 2004. Methods for RNA extraction, cDNA preparation and analysis of CFTR transcripts. J Cyst Fibros 3: Suppl 2 11-15. (Pubitemid 40045558)
27. Raychaudhuri S, Stuart JM, Altman RB. 2000. Principal components analysis to summarize microarray experiments: Application to sporulation time series. Pac Symp Biocomput 2000:455-466.
28. Streefland M, van de Waterbeemd B, Happe H, van der Pol LA, Beuvery EC, Tramper J, Martens DE. 2007. PAT for vaccines: The first stage of PAT implementation for development of a well-defined whole-cell vaccine against whooping cough disease. Vaccine 25(16):2994-3000.
29. Thalen M, van den IJssel J, Jiskoot W, Zomer B, Roholl P, de Gooijer C, Beuvery C, Tramper J. 1999. Rational medium design for Bordetella pertussis: Basic metabolism. J Biotechnol 75(2-3):147-159. (Pubitemid 29486614)
30. Thalen M, Venema M, van den IJssel J, Berwald L, Beuvery C, Martens D, Tramper J. 2006. Effect of relevant culture parameters on Pertussis toxin expression by Bordetella pertussis. Biologicals 34(3): 213-220. (Pubitemid 44216164)
31. Thalen M, van der Ark A, van den IJssel J, van Straaten I, Jansen D, Beuvery C, Martens D, Tramper J. 2008. Improving the cellular pertussis vaccine: Increased potency and consistency. Vaccine 26(5):653-663.
32. van Sprang ENM, Ramaker H-J, Streefland M, van der Pol LA, Beuvery EC, Smilde AK. 2007. Manufacturing vaccines: An Illustration of Using PAT Tools for Controlling the Cultivation of Bordetella pertussis. Qual Eng 19(4):373-384.
33. Xing D, Das RG, O'Neill T, Corbel M, Dellepiane N, Milstien J. 2001. Laboratory testing of whole cell pertussis vaccine: A WHO proficiency study using the Kendrick test. Vaccine 20(3-4):342-351. (Pubitemid 32973775)
34. Yoon SH, Han MJ, Lee SY, Jeong KJ, Yoo JS. 2003. Combined transcriptome and proteome analysis of Escherichia coli during high cell density culture. Biotechnol Bioeng 81(7):753-767.