WHO Expert Committee on Biological Standardization
Forty-seventh Report
Technical Report Series, No 878
World Health Organization
ISBN-13    9789241208789 ISBN-10    9241208783
Order Number    11000878 Format    E-book collection (PDF)
Price    CHF    20.00 / US$    24.00 Developing countries:    CHF    14.00
English     1998        107   pages
Table of contents
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This report presents the recommendations of a WHO expert committee commissioned to coordinate a range of research and other activities needed to assure the purity, potency, safety, and stability of biological products used in medicine. Work includes the development and adoption of detailed requirements for the manufacturing, licensing, and control of vaccines and other biologicals. The committee also coordinates the establishment of international reference materials for measuring the potency and other characteristics of biological products. These reference materials are used worldwide and play a crucial role in ensuring the comparability of products on a global basis.

The report has three parts. The first provides a brief discussion of general issues that shape the committee's work. Issues discussed include the implications of reverse transcriptase activity in avian cells, the need for reference preparations for evaluating hepatitis B, hepatitis C, and HIV diagnostic kits, and progress towards the standardization of gene-amplification methods for the viral safety testing of blood and blood products. The second part summarizes activities relating to the status of some 24 biological reference preparations categorized as antibiotics, antibodies, blood products and related substances, cytokines, endocrinological and related substances, toxins, and other substances.
The third and most extensive part issues detailed requirements for the use of animal cells as in vitro substrates for the production of biologicals, guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines, and guidelines for assuring the quality of DNA vaccines.