Guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines

World Health Organization - Technical Report Series

Volumn , Issue 941, 2007, Pages 57-81

  Robertson, J ^a   Ackland, J ^b   Holm, A ^c  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

^b Biologics Consulting Group Inc   (United States)

^c DANISH MEDICINES AGENCY   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOKINE; DNA; DNA VACCINE;

AUTOIMMUNITY; BIOLOGICAL ACTIVITY; CELL LINE; DRUG POTENCY; DRUG PURITY; DRUG STERILITY; GENE; GENE INSERTION; GENE SEQUENCE; GENOTOXICITY; HISTORY; HOST CELL; HUMAN; IMMUNOGENICITY; IMMUNOPATHOLOGY; MEDICAL DOCUMENTATION; MEDICAL INFORMATION; PLASMID; PRACTICE GUIDELINE; PROCESS CONTROL; PROCESS DEVELOPMENT; QUALITY CONTROL; REPRODUCTIVE TOXICITY; REVIEW; RISK; RISK ASSESSMENT; SAFETY; STANDARD; TOXICITY; VACCINE PRODUCTION;

EID: 39649124899     PISSN: 05123054     EISSN: None     Source Type: Book Series    
DOI: None     Document Type: Review

References (11)

1. Guidelines for assuring the quality of DNA vaccines. In: WHO Expert Committee on Biological Standardization. Forty-seventh report. Geneva, World Health Organization, 1998, Annex 3 (WHO Technical Report Series, No. 878).
2. Guidelines on nonclinical evaluation of vaccines. In: WHO Expert Committee on Biological Standardization. Fifty-fourth Report. Geneva, World Health Organization, 2005, Annex 1 (WHO Technical Report Series, No. 927).
3. Guidelines on clinical evaluation of vaccines: regulatory expectations. In: WHO Expert Committee on Biological Standardization. Fifty-second report. Geneva, World Health Organization, 2004, Annex 1 (WHO Technical Report Series, No. 924).
4. Good manufacturing practices for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-seventh report. Geneva, World Health Organization, 2003, Annex 4 (WHO Technical Report Series, No. 908).
5. Good manufacturing practices for biological products. In: WHO Expert Committee on Biological Standardization. Forty-second report. Geneva, World Health Organization, 1992, Annex 1 (WHO Technical Report Series, No. 822).
6. Ledwith BJ et al. Plasmid DNA vaccines: assay for integration into host genomic DNA. Developments in Biologicals, 2000, 104:33-43.
7. Ledwith BJ et al. Plasmid DNA vaccines: investigation of integration into host cellular DNA following intramuscular injection in mice. Intervirology, 2000, 43:258-272.
8. Kim BM et al. In vivo kinetics and biodistribution of a HIV-1 DNA vaccine after administration in mice. Archives of Pharmacal Research, 2003, 26:493-498.
9. Pilling AM et al. The assessment of local tolerance, acute toxicity, and DNA biodistribution following particle-mediated delivery of a DNA vaccine to minipigs. Toxicolologic Pathology, 2002, 30:298-305.
10. Bureau MF et al. Intramuscular plasmid DNA electrotransfer: biodistribution and degradation. Biochimica Biophysica Acta, 2004, 1676:138-148.
11. Wang Z et al. Detection of integration of plasmid DNA into host genomic DNA following intramuscular injection and electroporation. Gene Therapy, 2004, 11:711-721.