WHO Expert Committee on Biological Standardization

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 antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national control authorities, contains recommendations for the production and control of oral poliomyelitis vaccine, an amendment to the requirements for meningococcal polysaccharide vaccine, and a decision-tree for setting priorities in the development of reference materials. Also included is an addendum to the guidelines for the preparation, characterization, and establishment of standards and reference reagents for biological substances.