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The Committee reports on general issues discussed 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 regulatory authorities, contains guidelines on the production and quality control of candidate tetravalent dengue virus vaccines and recommendations for the preparation, characterisation and establishment of international and other biological reference standards.

This report presents the recommendations of a WHO Expert Committee commissioned to co-ordinate activities leading to the adoption of international requirements for the production and quality 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 material for various antibodies, antigens, blood products, cytokines and toxins. The second part of the report, of particular interest to manufacturers and national control authorities, contains two specific sets of requirements: for Haemophilus influenzae type b conjugate vaccines and for oral poliomyelitis vaccine. Also included are lists of recommendations and guidelines for biological substances used in medicine.

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and quality 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 attention of the Committee and provides information on issues relevant to international guidelines recommendations and other matters related to the manufacture and quality control of biologicals. This is followed by information on the status and development of reference materials for bovine spongiform encephalopathy various antigens blood products cytokines growth factors and endocrinological substances. The second part of the report of particular interest to manufacturers and national control authorities contains sets of recommendations for the production and control of poliomyelitis vaccine (oral) and poliomyelitis vaccine (inactivated) and guidelines for the production and control of live attenuated Japanese encephalitis vaccine. Also included are lists of recommendations and guidelines for biological substances used in medicine and other relevant documents.