MARC details
000 -LEADER |
fixed length control field |
02115cam a2200313 4500 |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
International Standard Book Number |
9241207477 |
035 ## - |
-- |
(Sirsi) 9241207477 |
060 ## - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
Classification number |
QW 805 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
870313s1987 eng |
110 2# - MAIN ENTRY--CORPORATE NAME |
Corporate name or jurisdiction name as entry element |
WHO Study Group on Biologicals. |
242 10 - TRANSLATION OF TITLE BY CATALOGING AGENCY |
Title |
Acceptabilité des substrats cellulaires pour la production de substances biologiques : |
Remainder of title |
rapport d'un Groupe d' étude de l' OMS [réuni à Genève, 18-19 novembre 1986] |
245 00 - TITLE STATEMENT |
Title |
Acceptability of cell substrates for production of biologicals : |
Remainder of title |
report of a WHO study group [meeting held in Geneva from 18 to 19 November 1986] |
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
Place of publication, distribution, etc. |
Geneva : |
Name of publisher, distributor, etc. |
World Health Organization, |
Date of publication, distribution, etc. |
1987. |
300 ## - PHYSICAL DESCRIPTION |
Extent |
29 p. |
440 #0 - SERIES STATEMENT/ADDED ENTRY--TITLE |
Title |
World Health Organization technical report series ; |
Volume/sequential designation |
no. 747 |
500 ## - GENERAL NOTE |
General note |
Russian version of nos. 728-749 bound together (barcode no. 00073792). |
520 3# - SUMMARY, ETC. |
Summary, etc. |
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. |
546 ## - LANGUAGE NOTE |
Language note |
eng fre rus spa. |
550 ## - ISSUING BODY NOTE |
Issuing body note |
WHODOC |
561 ## - OWNERSHIP AND CUSTODIAL HISTORY |
History |
WHO monograph |
596 ## - |
-- |
4 |
650 02 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Vaccines. |
650 02 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name as entry element |
Cell line. |
690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) |
Topical term or geographic name as entry element |
Pharmacology, Toxicology and Clinical Technology. |
710 2# - ADDED ENTRY--CORPORATE NAME |
Corporate name or jurisdiction name as entry element |
World Health Organization. |
856 ## - ELECTRONIC LOCATION AND ACCESS |
Uniform Resource Identifier |
<a href="https://apps.who.int/iris/">https://apps.who.int/iris/</a> |
856 ## - ELECTRONIC LOCATION AND ACCESS |
Uniform Resource Identifier |
<a href="https://apps.who.int/iris/">https://apps.who.int/iris/</a> |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Source of classification or shelving scheme |
NLM Classification Scheme |
Koha item type |
Books |