Adaptation of the WHO guideline for residual DNA in parenteral vaccines produced on continuous cell lines to a limit for oral vaccines

Developments in Biologicals

Volumn 123, Issue , 2006, Pages 35-44

  Lebron, J A ^a   Troilo, P J ^a   Pacchione, S ^a   Griffiths, T G ^a   Harper, L B ^a   Mixson, L A ^a   Jackson, B E ^a   Michna, L ^a   Barnum, A B ^a   Denisova, L ^a   Johnson, C N ^a   Maurer, K L ^a   Morgan Hoffman, S ^a   Niu, Z ^a   Roden, D F ^a   Wang, Z ^a   Wolf, J J ^a   Hamilton, T R ^a   Laux, K M ^a   Soper, K A ^a   Ledwith, B J ^a   more..

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEOXYRIBONUCLEASE; DNA; VACCINE;

ANIMAL; CELL LINE; CERCOPITHECUS; CONFERENCE PAPER; ENDOCYTOSIS; ENDOSOME; FEMALE; HUMAN; MALE; ORAL DRUG ADMINISTRATION; PHYSIOLOGY; PRACTICE GUIDELINE; STANDARD; VERO CELL; WORLD HEALTH ORGANIZATION;

ADMINISTRATION, ORAL; ANIMALS; CELL LINE; CERCOPITHECUS AETHIOPS; DEOXYRIBONUCLEASES; DNA; ENDOCYTOSIS; ENDOSOMES; FEMALE; HUMANS; MALE; PRACTICE GUIDELINES; VACCINES; VERO CELLS; WORLD HEALTH ORGANIZATION;

EID: 33644624022     PISSN: 14246074     EISSN: None     Source Type: Book Series    
DOI: None     Document Type: Conference Paper

References (5)

1. Petricciani J, Loewer J: An overview of cell DNA issues, in Brown F, Lewis AM, Peden K, Krause P (eds): Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development. Dev Biol. Basel, Karger, 2001, vol 106, pp 275-282.
2. World Health Organization. Acceptability of cell substrates for production of Biologicals. Report of a WHO Study Group. Geneva, Switzerland, 1987 (World Health Organization Technical Report Series 747).
3. World Health Organization. WHO Expert Committee on Biological Standardization. Geneva, Switzerland, 1998 (World Health Organization Technical Report Series 878).
4. Israel MA, Chan HW, Hourihan SL, Rowe WP, Martin MA: Biological activity of polyoma viral DNA in mice and hamsters. J Virol 1979; 29 (3): 990-996.
5. Madhami HD, Leadon SA, Allen Smith C, Hanawalt PC: A DNA in African Green Monkey Cells is Organized into Extremely Long Tandem Arrays. J Biol Chem 1986; 261 (5): 2314-2318.