WHO Expert Committee on Biological Standardization : thirty-ninth report, meeting held in Geneva from 11 to 19 October 1988

General -- Substances: Antibiotics -- Antibodies -- Antigens -- Blood products -- Endocrinological and related substances -- Cytokines -- Allergens -- Miscellaneous -- Requirements for Biological Substances -- Annexes

A record of new or revised requirements for specific biological substances and an alert to ongoing or planned research likely to affect requirements in the near future. Readers are given a brief review of changes in the status, availability, development or testing of international reference materials for selected antibiotics, antibodies, antigens, blood products, endocrinological substances, cytokines, and allergens, and for snake venoms, antivenoms, and digitalis. The main part of the report issues revised WHO procedures for evaluating the acceptability of vaccines proposed to UN agencies for use in immunization programmes, followed by revised requirements for the manufacturing and control of hepatitis B vaccines made by recombinant DNA techniques and for human interferons prepared from lymphoblastoid cells. The most extensive section, which runs some 80 pages, issues revised requirements for the collection, processing, and quality control of blood, blood components, and plasma derivatives. Revisions are in line with the need for stringent requirements to safeguard the quality of blood and blood products, particularly against contamination with HIV and hepatitis B virus. Separate sections set out requirements for the collection of source materials, for single-donor and small-pool products, for the manufacture of blood products,for the control of plasma fractions, and for national control laboratories. Details range from precise criteria for donor selection and testing for disease markers, through requirements governing conditions of manufacturing and storage, to a list of tests that must be performed to control the quality of plasma fractions. To assure the safety of blood supplies, readers are advised to follow requirements at all stages in the process, from the collection of the source material to the quality control of the final products.