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.