Acceptability of cell substrates for production of biologicals : (Record no. 11107)

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
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Home library Current library Shelving location Date acquired Permanent Item Total Checkouts Full call number Barcode Date last seen Copy number Bill Date Koha item type
    NLM Classification Scheme     WHO HQ WHO HQ READING-RM 18/07/1996 N   HQ SERIAL 00000693 12/09/2016 1 12/09/2016 Books
Withdrawn   NLM Classification Scheme     WHO HQ WHO HQ BORROWABLE-COLL-STACKS 18/07/1996 Y   QW 805 87WH 00000694 12/09/2016 2 12/09/2016 Books
    NLM Classification Scheme     WHO HQ WHO HQ ONLINE-IRIS 25/09/2002 Y   QW 805 87WH O9241207477 12/09/2016 3 12/09/2016 Books
    NLM Classification Scheme     WHO HQ WHO HQ ONLINE-IRIS 03/11/2004 Y   HQ SERIAL RUS O9241207477RUS 12/09/2016 1 12/09/2016 Books
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