WHO Expert Committee on Biological Standardization. Forty-sixth Report.

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international requirements for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the Committee's attention and provides information on the status and development of reference materials for various antibiotics, antibodies, antigens, blood products, cytokines, endocrinological and related substances and toxins. The second part of the report, of particular relevance to manufacturers and national control authorities, contains the revised list of laboratories approved by WHO for the production of yellow fever vaccine, revised requirements for yellow fever vaccine, an amendment to the General Requirements for the Sterility of Biological Substances, and a summary protocol for the batch release of virus vaccines.