Chemistry International
Vol. 22, No. 6, November 2000

2000, Vol. 22
No. 6 (November)
..News from ICSU
..News and Notices
..New Projects
..Awards and Prizes
..New Books
..Provisional Recommendations
..Reports from Commissions
..In Memorium
..Conference Announcements
..Conference Calendar

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Chemistry International
Vol. 22, No. 6
November 2000


New Publication from the World Health Organization

WHO Expert Committee on Biological Standardization, 48 th Report, Technical Report Series No. 889 1999, vi + 111 pages (available in English; French and Spanish in preparation), ISBN 92-4-120889-9, CHF 23.-/USD 20.70; In developing countries: CHF 16.10, Order No. 1100889.

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 four parts. The first provides a brief discussion of general issues that shape the committee's work. Issues discussed include progress in the establishment of cytokine standards, efforts to harmonize technical requirements for vaccine production and licensing, implications for vaccine requirements of the Agreement on Technical Barriers to Trade of the World Trade Organization (WTO), and safety questions arising from the detection by very sensitive polymerase chain-reaction-based methods of low levels of reverse transcriptase activity in live viral vaccines prepared in chicken cells.

The second part provides a brief review of the status of some 15 international guidelines, requirements, and related documents relevant to the manufacture and quality control of biologicals. Part 3 summarizes activities relating to the status and development of biological reference materials for various antibodies, antibiotics, blood products and related substances, cytokines and growth factors, and other substances requiring international reference materials.

The fourth and most extensive part issues detailed guidelines for the production and control of synthetic peptide vaccines, requirements for tick-borne encephalitis vaccine (inactivated), and guidelines for thromboplastins and plasma used to control oral anti-coagulant therapy. Also included are an amendment to the requirements for hepatitis B vaccine made by recombinant DNA techniques, and a report on the standardization and calibration of cytokine immunoassays.



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