Vaccine Cell Substrates 2004: 29th June - 1st July, Rockville, MD, USA

Expert Review of Vaccines

Volumn 3, Issue 6, 2004, Pages 633-638

  Sheets, Rebecca ^a   Petricciani, John ^b  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b CancerVax Corporation   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DNA VACCINE;

ANIMAL CELL; ANIMAL EXPERIMENT; BOVINE SPONGIFORM ENCEPHALOPATHY; CARCINOGENICITY; CONFERENCE PAPER; DRUG DISTRIBUTION; DRUG SAFETY; HUMAN; HUMAN CELL; MOUSE; NONHUMAN; POLYOMA VIRUS; PRIORITY JOURNAL; VACCINATION;

ANIMALS; CELL LINE; HUMANS; NEOPLASMS, EXPERIMENTAL; QUALITY CONTROL; VIRAL VACCINES; VIRUS CULTIVATION; VIRUSES;

EID: 9644291595     PISSN: 14760584     EISSN: None     Source Type: Journal    
DOI: 10.1586/14760584.3.6.633     Document Type: Conference Paper

References (17)

1. Petricciani JC. Cell line issues: historical and future perspectives. Dev. Biol. Stand. 76, 5-11 (1992).
2. Petricciani JC. Regulatory philosophy and acceptability of cells for the production of biologicals. Develop. Biol. Stand. 75, 9-15 (1991).
3. Lubiniecki AS. Continuous cell-line considerations. BioPr. Tech. 10, 495-513 (1990).
4. Hilleman MR. History, precedent and progress in the development of mammalian cell-culture systems for preparing vaccines: safety considerations revisited. J. Med. Virol. 31, 5-12 (1990).
5. Ellis RW, Gerety RJ. Key issues in the selection of an expression system for vaccine antigens. J. Med. Virol. 31, 54-58 (1990).
6. Code of Federal Regulations. Title 9, Part 113 (2004).
7. International Conference on Harmonization (ICH) Q5A document: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. Fed. Reg. 63 (185), 51074-51084, (1998).
8. CBER's Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993).
9. Nichols WW, Lardenoije R, Ledwith BJ et al. Propagation of adenoviral vectors: use of PER.C6 cells. In: Adenoviral Vectors for Gene Therapy. Curiel DT, Douglas JT (Ed.). Academic Press, NY, USA, 129-166 (2002).
10. Report of the meting of the study group on biologicals. WHO Technical Report Series, No. 747 (1987).
11. Petricciani JP, Regan PJ. Risk of neoplastic transformation from cellular DNA: calculations using the oncogene model. Develop. Biol. Std 68, 43-49 (1987).
12. Temin H. Overview of biological effects of addition of DNA molecules to cells. J. Med. Virol. 31, 13-17 (1990).
13. Kurth R. Risk potential of the chromosomal insertion of foreign DNA. Ann. NY Acad. Sci. 772, 140-151 (1995).
14. Dortant PM, Claassen JTM, van Krey CF, van Steenis V, Wester PW. Risk assessment on the carcinogenic potential of hybridoma cell DNA: implications for residual contaminating cellular DNA in biological products. Biologicals 25, 381-390 (1997).
15. Krause PR, Lewis AM Jr. Safety of viral DNA in biological products. Biologicals 26, 317-320 (1998).
16. Slide presentation from Vaccine Cell Substrates 2004 www.niaid.nih.gov/ daids/vaccine/substrate.htm Accessed November, 2004
17. International Association for Biologicals 2004 www.iabs.org Accessed November, 2004