Chemistry International
Vol. 23, No. 6
November 2001
New
Publications from the World Health Organization
WHO Expert Committee on Biological Standardization, 49th
Report, WHO Technical Report Series No. 897, 2000, vi + 106 pages (available
in English; French and Spanish in preparation), ISBN 92-4-120897-X,
CHF 20.-/USD 18.00; In developing countries: CHF 14.-, Order No. 1100897.
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 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, 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 areas 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.