000			02115cam a2200313 4500
020			_a9241207477
035			_a(Sirsi) 9241207477
060			_aQW 805
110	2		_aWHO Study Group on Biologicals.
242	1	0	_aAcceptabilité des substrats cellulaires pour la production de substances biologiques : _brapport d'un Groupe d' étude de l' OMS [réuni à Genève, 18-19 novembre 1986]
245	0	0	_aAcceptability of cell substrates for production of biologicals : _breport of a WHO study group [meeting held in Geneva from 18 to 19 November 1986]
260			_aGeneva : _bWorld Health Organization, _c1987.
300			_a29 p.
440		0	_aWorld Health Organization technical report series ; _vno. 747
500			_aRussian version of nos. 728-749 bound together (barcode no. 00073792).
520	3		_aA 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.
546			_aeng fre rus spa.
550			_aWHODOC
561			_aWHO monograph
596			_a4
650	0	2	_aVaccines.
650	0	2	_aCell line.
690			_aPharmacology, Toxicology and Clinical Technology.
710	2		_aWorld Health Organization.
856			_uhttps://apps.who.int/iris/
856			_uhttps://apps.who.int/iris/
008			870313s1987 eng
942			_2NLM _cMONOGRAPH
999			_c11107 _d11107