Evaluation of cell substrates for the production of biologicals: Revision of WHO recommendations. Report of the WHO Study Group on Cell Substrates for the Production of Biologicals, 22-23 April 2009, Bethesda, USA

Biologicals

Volumn 38, Issue 1, 2010, Pages 162-169

  Knezevic, I ^a   Stacey, G ^b   Petricciani, J ^c   Sheets, R ^d  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

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

^c Palm Springs   (United States)

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

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; DNA; VACCINE;

ANIMAL CELL CULTURE; BACTERIUM CONTAMINATION; CARCINOGENICITY; CELL LINE; CONFERENCE PAPER; CYTOLOGY; DRUG MANUFACTURE; DRUG SAFETY; GOOD MANUFACTURING PRACTICE; IN VITRO STUDY; IN VIVO STUDY; INSECT CELL; MYCOPLASMA; NONHUMAN; NUCLEIC ACID AMPLIFICATION; PRIORITY JOURNAL; QUALITY CONTROL; RETROVIRUS; STANDARDIZATION; STEM CELL; VACCINE PRODUCTION; VIRUS DETECTION; WORLD HEALTH ORGANIZATION;

ANIMALS; BIOLOGICAL PRODUCTS; CELLS; CERCOPITHECUS AETHIOPS; DRUG CONTAMINATION; HEALTH PLANNING GUIDELINES; HUMANS; INTERNATIONALITY; MYCOPLASMA; NUCLEIC ACID AMPLIFICATION TECHNIQUES; SOCIETIES, SCIENTIFIC; VERO CELLS; WORLD HEALTH ORGANIZATION;

MYCOPLASMA;

EID: 77649182624     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2009.08.019     Document Type: Conference Paper

References (5)

1. Requirements for the use of animal cells as in vitro substrates for the production of biologicals. Forty-seventh Report. WHO expert committee on biological standardization (1998), World Health Organization, Geneva [WHO Technical Report Series, No. 878, annex 1]
2. WHO Study Group on cell substrates for production of biologicals, Geneva, Switzerland, 11-12 June 2007. Conference Report. Biologicals 36 (2008) 203-211
3. Sheng-Fowler L., Lewis A., and Peden K. Quantitative determination of the infectivity of the proviral DNA of a retrovirus in vitro: evaluation of methods for DNA inactivation. Biologicals 37 (2009) 259-269
4. Sheng-Fowler L., Lewis A., and Peden K. Issues associated with residual cell-substrate DNA in viral vaccines. Biologicals 37 (2009) 190-195
5. Recommendations for the preparation, characterization and establishment of international and other biological reference standards (revised 2004). Fifty-fifth Report. WHO expert committee on biological standardization (2005), World Health Organization, Geneva [WHO Technical Report Series 932, annex 2]