Acceptability of cell substrates for production of biologicals :
Acceptability of cell substrates for production of biologicals : report of a WHO study group [meeting held in Geneva from 18 to 19 November 1986]
= Acceptabilité des substrats cellulaires pour la production de substances biologiques : rapport d'un Groupe d' étude de l' OMS [réuni à Genève, 18-19 novembre 1986]
- Geneva : World Health Organization, 1987.
- 29 p.
- World Health Organization technical report series ; no. 747 .
Russian version of nos. 728-749 bound together (barcode no. 00073792).
A brief yet highly significant analysis of issues associated with the use of eukaryotic and prokaryotic cells in the production of biologicals. The report considers two main types of issues: first, the acceptability of developing a biological product in a new cell system when the same generic product is already being manufactured by an approved method, and second, the degree of risk associated with certain classes of possible contaminants in the product. These include heterogeneous contaminating DNA, viruses, and transforming poteins. For each contaminant, the report describes and analyses the potential risks to humans and, where appropriate, categorizes and classifies these risks. The report also advocates basic principles of manufacturing and testing that can help minimize the likelihood of risks to human recipients of products manufactured in continuous cell lines.
eng fre rus spa.
WHODOC
9241207477
Vaccines.
Cell line.
QW 805
Russian version of nos. 728-749 bound together (barcode no. 00073792).
A brief yet highly significant analysis of issues associated with the use of eukaryotic and prokaryotic cells in the production of biologicals. The report considers two main types of issues: first, the acceptability of developing a biological product in a new cell system when the same generic product is already being manufactured by an approved method, and second, the degree of risk associated with certain classes of possible contaminants in the product. These include heterogeneous contaminating DNA, viruses, and transforming poteins. For each contaminant, the report describes and analyses the potential risks to humans and, where appropriate, categorizes and classifies these risks. The report also advocates basic principles of manufacturing and testing that can help minimize the likelihood of risks to human recipients of products manufactured in continuous cell lines.
eng fre rus spa.
WHODOC
9241207477
Vaccines.
Cell line.
QW 805