WHO Expert Committee on Biological Standardization
Forty-ninth Report
WHO Technical Report Series, No 897
World Health Organization
ISBN-13    9789241208970 ISBN-10    924120897X
Order Number    11000897 Format    E-book collection (PDF)
Price    CHF    20.00 / US$    24.00 Developing countries:    CHF    14.00
English     2000        109   pages
Summary
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Summary
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 recommendations 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 four parts. The first provides a brief discussion of general concerns being addressed by WHO in its efforts to ensure the safety and efficacy of biological medicines. Topics discussed include the safety of vaccines prepared using chicken cells, and the proposed introduction of International Nonproprietary Names for products manufactured by biotechnological processes. Also summarized are the results of an independent review of WHO's remit and activities in the field of biologicals.
The second part provides a brief review of the status of various international guidelines and recommendations relevant to the manufacture and quality control of biologicals, and identifies recommendations in need of revision. Part three summarizes activities relating to the status and development of biological reference materials for selected antibodies, antigens and related substances, blood products and related substances, cytokines, and other substances requiring international reference materials.
As guidance for national control authorities and manufacturers, the fourth and most extensive part issues detailed recommendations for the production and quality control of Haemophilus influenzae type b conjugate vaccines, and provides an addendum to the 1990 requirements for oral poliomyelitis vaccine. The updated recommendations for the production and control of H. influenzae type b vaccine reflect recent developments and advances in vaccine control strategies, and focus in particular on physicochemical tests to monitor consistency of production of the polysaccharide, the protein carrier, and the bulk conjugate. For poliomyelitis vaccine, the addendum responds to the need for additions in four areas. These include new tests for ensuring that the working seed stocks are free of detectable sequences of simian virus 40, guidance on technical performance of the MAPREC assay for poliovirus type 3, the need to improve laboratory containment of wild polioviruses, and guidance on antibody screening tests for colony-bred or intensively monitored animals to encourage their use as sources of primary kidney-cell cultures.
The report concludes with a 30-page inventory of WHO international biological reference preparations held and distributed by the WHO International Laboratories for Biological Standards.