Good Manufacturing Practices production and analysis of a DNA vaccine against dental caries

Acta Pharmacologica Sinica

Volumn 30, Issue 11, 2009, Pages 1513-1521

  Yang, Ya Ping ^a   Li, Yu Hong ^a   Zhang, Ai Hua ^b   Bi, Lan ^b   Fan, Ming Wen ^a  

^a WUHAN UNIVERSITY   (China)

^b Wuhan Institute of Biological Products   (China)

Author keywords

Dental caries; DNA vaccine; Good Manufacturing Practices

Indexed keywords

ALKALI; CHITOSAN; DNA VACCINE; ENDOTOXIN; GENOMIC DNA; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G ANTIBODY; PGJA P VAX; PROTEIN; PVAX1; RNA; UNCLASSIFIED DRUG; VACCINE;

ALKALINITY; ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BACTERIUM; CLINICAL ASSESSMENT; COLUMN CHROMATOGRAPHY; CONTROLLED STUDY; DENTAL CARIES; DENTIN; DRUG DETERMINATION; DRUG EFFICACY; DRUG MANUFACTURE; ENAMEL; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FREEZE DRYING; GNOTOBIOTICS; GOOD MANUFACTURING PRACTICE; IMMUNITY; IMMUNOGLOBULIN BLOOD LEVEL; LABORATORY TEST; LARGE SCALE PRODUCTION; MOUSE; NONHUMAN; PLASMID; PRACTICE GUIDELINE; PRECIPITATION; PURIFICATION; QUALITY CONTROL; RAT; SALIVA; VACCINATION;

ANIMALS; CHITOSAN; DENTAL CARIES; DRUG INDUSTRY; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; GENE TRANSFER TECHNIQUES; GENETIC VECTORS; GUIDELINES AS TOPIC; IMMUNOGLOBULIN A, SECRETORY; IMMUNOGLOBULIN G; MICE; MICE, INBRED BALB C; PLASMIDS; QUALITY CONTROL; RATS; RATS, WISTAR; REPRODUCIBILITY OF RESULTS; SALIVA; VACCINES, DNA;

EID: 70449344464     PISSN: 16714083     EISSN: 17457254     Source Type: Journal    
DOI: 10.1038/aps.2009.152     Document Type: Article

References (39)

1. Bowen WH. Do we need to be concerned about dental caries in the coming millennium? Crit Rev Oral Biol Med 2002; 13: 126-131 .
2. Taubman MA, Nash DA. The scientific and public-health imperative for a vaccine against dental caries. Nat Rev Immunol 2006; 6: 555-563
3. Smith DJ. Dental caries vaccines: prospects and concerns. Crit Rev Oral Biol Med 2002; 13: 335-349
4. Gregory RL. Dental caries vaccines: science and status. Compendium, (1994 OCT) 15 (10) 1282, 1284, 1286 passim;quiz 1294.
5. Russell MW, Childers NK, Michalek SM, Smith DJ, Taubman MA. A Caries Vaccine? The state of the science of immunization against dental caries. Caries Res 2004; 38: 230-235
6. Cui Z. DNA Vaccine. Adv Genet 2005; 54: 257-289
7. Xu QA, Yu F, Fan MW, Bian Z, Chen Z, Fan B, et al. Immunogenicity and persistence of a targeted anti-caries DNA vaccine. J Dent Res 2006; 85: 915-918 (Pubitemid 44578602)
8. Zhang F, Li YH, Fan MW, Jia R, Xu QA, Guo JH, et al. Enhanced efficacy of CTLA-4 fusion anti-caries DNA vaccines in gnotobiotic hamsters. Acta Pharmacol Sin 2007; 28: 1236-1242
9. Xu QA, Yu F, Fan MW, Bian Z, Chen Z, Peng B, et al. Protective efficacy of a targeted anti-caries DNA plasmid against cariogenic bacteria infections. Vaccine 2007; 25: 1191-1195
10. Jia R, Guo JH, Fan MW, Bian Z, Chen Z, Fan B, et al. Immunogenicity of CTLA4 fusion anti-caries DNA vaccine in rabbits and monkeys. Vaccine 2006; 24: 5192-5200 (Pubitemid 43818192)
11. Liu C, Fan M, Xu Q, Li Y. Biodistribution and expression of targeted fusion anti-caries DNA vaccine pGJA-P/VAX in mice. J Gene Med 2008; 10: 298-305.
12. Robertson J, Griffiths E. WHO guidelines for assuring the quality of DNA vaccines. Biologicals 1998; 26: 205-212
13. FDA. Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications. Biotechnology Law Report 2007; 26: 641-648
14. FDA. Points to consider on plasmid DNA vaccine for preventive infectious disease indications. 1996.
15. SFDA. Guidelines for Preclinical Study of Prophylactic DNA Vaccine. 2003.
16. WHO. Guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines. WHO Technical Report 2007; Series No 941.
17. WHO. Good manufacturing practices for pharmaceutical products. WHO Technical Report 2003; Series No 908.
18. WHO. Good manufacturing practices for biological products. WHO Technical Report 1992; Series No 822.
19. Stuart CA, Griffin AM, Baker ME. Relationships of Coliform Organisms. J Bacteriol 1938; 36: 391-410.
20. Diogo MM, Queiroz JA, Monteiro GA, Martins SA, Ferreira GN, Prazeres DM. Purification of a cystic fibrosis plasmid vector for gene therapy using hydrophobic interaction chromatography. Biotechnol Bioeng 2000; 68: 576-583
21. Diogo MM, Ribeiro SC, Queiroz JA, Monteiro GA, Tordo N, Perrin P, et al. Production, purification and analysis of an experimental DNA vaccine against rabies. J Gene Med 2001; 3: 577-584
22. ScholZ E. Karl Fischer Titration: determination of water. Berlin- Heidelerg: Springer-Verlag; 1984.
23. May JC, Grim E, Wheeler RM, West J. Determination of residual moisture in freeze-dried viral vaccines: Karl Fischer gravimetric and thermogravimetric methodologies. J Biol Stand 1982; 10: 249-259
24. Li YH, Fan MW, Bian Z, Chen Z, Zhang Q, Yang HR. Chitosan-DNA microparticles as mucosal delivery system: synthesis, characterization and release in vitro. Chin Med J (Engl) 2005; 118: 936-941 (Pubitemid 40867465)
25. Navia JM. Animal models in dental research. Tuscaloosa: University of Alabama Press; 1977. p 280-307.
26. Zhang P, Jespersgaard C, Lamberty-Mallory L, Katz J, Huang Y, Hajishengallis G, et al. Enhanced immunogenicity of a genetic chimeric protein consisting of two virulence antigens of Streptococcus mutans and protection against infection. Infect Immun 2002; 70: 6779-6787
27. Keyes PH. Dental caries in the molar teeth of rats. II. A method for diagnosing and scoring several types of lesions simultaneously. J Dent Res 1958; 37: 1088-1099
28. Urthaler J, Ascher C, Wohrer H, Necina R. Automated alkaline lysis for industrial scale cGMP production of pharmaceutical grade plasmid- DNA. J Biotechnol 2007; 128: 132-149
29. Quaak SG, van den Berg JH, Toebes M, Schumacher TN, Haanen JB, Beijnen JH, et al. GMP production of pDERMATT for vaccination against melanoma in a phase I clinical trial. Eur J Pharm Biopharm 2008; 70: 429-438
30. Magalhaes PO, Lopes AM, Mazzola PG, Rangel-Yagui C, Penna TC, Pessoa A Jr. Methods of endotoxin removal from biological preparations: a review. J Pharm Pharm Sci 2007; 10: 388-404. (Pubitemid 350079921)
31. Montbriand PM, Malone RW. Improved method for the removal of endotoxin from DNA. J Biotechnol 1996; 44: 43-46
32. Ferreira GN, Cabral JM, Prazeres DM. Development of process flow sheets for the purification of supercoiled plasmids for gene therapy applications. Biotechnol Prog 1999; 15: 725-731
33. Horn NA, Meek JA, Budahazi G, Marquet M. Cancer gene therapy using plasmid DNA: purification of DNA for human clinical trials. Hum Gene Ther 1995; 6: 565-573
34. Stadler J, Lemmens R, Nyhammar T. Plasmid DNA purification. J Gene Med 2004; 6 Suppl 1: S54-66.
35. Ferreira GN, Monteiro GA, Prazeres DM, Cabral JM. Downstream processing of plasmid DNA for gene therapy and DNA vaccine applications. Trends Biotechnol 2000; 18: 380-388
36. Jespersgaard C, Hajishengallis G, Huang Y, Russell MW, Smith DJ, Michalek SM. Protective immunity against Streptococcus mutans infection in mice after intranasal immunization with the glucanbinding region of S mutans glucosyltransferase. Infect Immun 1999; 67: 6543-6549
37. Fontana M, Dunipace AJ, Stookey GK, Gregory RL. Intranasal immunization against dental caries with a Streptococcus mutansenriched fimbrial preparation. Clin Diagn Lab Immunol 1999; 6: 405-409
38. Koga T, Oho T, Shimazaki Y, Nakano Y. Immunization against dental caries. Vaccine 2002; 20: 2027-2044
39. Hajishengallis G, Nikolova E, Russell MW. Inhibition of Streptococcus mutans adherence to saliva-coated hydroxyapatite by human secretory immunoglobulin A (S-IgA) antibodies to cell surface protein antigen I/II: reversal by IgA1 protease cleavage. Infect Immun 1992; 60: 5057-5064