Tumorigenicity assessments of PER.C6® cells and of an Ad5-vectored HIV-1 vaccine produced on this continuous cell line

Developments in Biologicals

Volumn 123, Issue , 2006, Pages 251-263

  Ledwith, B J ^a   Lanning, C L ^a   Gumprecht, L A ^a   Anderson, C A ^a   Coleman, J B ^a   Gatto, N T ^a   Balasubramanian, G ^a   Farris, G M ^a   Kemp, R K ^a   Harper, L B ^a   Barnum, A B ^a   Pacchione, S J ^a   Mauer, K L ^a   Troilo, P J ^a   Brown, E R ^a   Wolf, J J ^a   Lebron, J A ^a   Lewis, J A ^a   Nichols, W W ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE; PRIMER DNA;

ANIMAL; BIOSYNTHESIS; CARCINOGEN TESTING; CELL LINE; CONFERENCE PAPER; GENE VECTOR; GENETICS; HAMSTER; HELA CELL; HUMAN; HUMAN ADENOVIRUS; MOUSE; NEOPLASM; NEWBORN; NUCLEOTIDE SEQUENCE; NUDE MOUSE; POLYMERASE CHAIN REACTION; RAT; RETINA; STANDARD; VIROLOGY;

ADENOVIRUSES, HUMAN; AIDS VACCINES; ANIMALS; ANIMALS, NEWBORN; BASE SEQUENCE; CARCINOGENICITY TESTS; CELL LINE, TRANSFORMED; CRICETINAE; DNA PRIMERS; GENETIC VECTORS; HELA CELLS; HUMANS; MICE; MICE, NUDE; NEOPLASMS; POLYMERASE CHAIN REACTION; RATS; RETINA;

EID: 33644622434     PISSN: 14246074     EISSN: None     Source Type: Book Series    
DOI: None     Document Type: Conference Paper

References (11)

1. Shiver JW, Emini EA: Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annual Review Medicine 2004;55:355-372.
2. Fallaux FJ, Bout A, Van Der Held I, Van Den Wollenberg DJM, Hehir KM, Keegan J et al: Human Gene Therapy 1998;9:1909-1917.
3. Nichols WW, Lardenoije R, Ledwith BJ, Brouwer K, Manam S, Vogels R et al: Propagation of adenoviral vectors: use of PER.C6® cells, in Curiel DT, Douglas JT (eds): Adenoviral Vectors for Gene Therapy. San Diego, Academic Press, 2002, pp 129-166.
4. WHO Technical Report Series: Acceptability of cell substrates for production of biologicals. Report of a WHO Study Group. World Health Organization, 1987, No. 747.
5. WHO Technical Report Series: WHO requirements for the use of animals cells as in vitro substrates for the production of biologicals (Requirements for Biological Substances No. 50), 1998, No. 878. Reproduced in Biologicals 1998;26:175-193.
6. Dortant PM, Claassen JJ, van Kreyl CF, van Steenis G, Wester PW: Risk assessment on the carcinogenic potential of hybridoma cell DNA: implications for residual contaminating cellular DNA in biological products. Biologicals 1997;25(4):381-390.
7. Palladino MA, Levinson AD, S vedersky LP, Obijeski JF: Safety issues related to the use of recombinant DNA-deri ved cell culture products: I. Cellular Components, in Spier R, Hennessen W (eds): Advances in Animal Cell Technology: Cell Engineering, Evaluation and Exploitation. Dev Biol Stand 1987, vol 66, pp 13-22.
8. Levinson AD, Svedersky LP, Palladino MA Jr: Tumorigenic Potential of DNA derived from mammalian cell lines. In vitro monograph 1985;6:161-165.
9. Mufson RA, Gesner T: Lack of tumorigenicity of cellular DNA and oncogene DNA in newborn Chinese hamsters. In vitro monograph, 1985;6:168-169.
10. Wierenga DE, Cogan J, Petricciani JC: Administration of tumour cell chromatin to immunosuppressed and non-immunosuppressed non-human primates. Biologicals 1995;23:221-224.
11. International Conference on Harmonization: Q5 A. Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, 1998.