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 antibiotics, antibodies, blood products, cytokines, endocrinological and related substances, toxins and other substances. The second part of the report, of particular relevance to manufacturers and national control authorities, contains requirements for the use of animal cells as in vitro substrates for the production of biologicals, guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines, as well as guidelines for assuring the quality of DNA vaccines.