WHO Expert Committee on Biological Standardization
Fifty-third Report
Technical Report Series, No 926
World Health Organization
ISBN-13    9789241209267 ISBN-10    9241209267
Order Number    11000926 Format    E-book collection (PDF)
Price    CHF    25.00 / US$    30.00 Developing countries:    CHF    17.50
English     2004        116   pages
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Summary
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international requirements for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the Committee's attention and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national control authorities, contains recommendations for the production and quality control of smallpox vaccine, an addendum to the recommendations for the production and quality control of meningococcal group C conjugate vaccines, guidelines on regulatory expectations related to the elimination, reduction or replacement of thiomersal in vaccines, and guidelines for the safe production and quality control of IPV manufactured from wild polioviruses.