title: WHO Expert Committee on Biological Standardization.
abstract: 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 regulatory authorities, contains recommendations for the production and quality control of meningococcal group C conjugate vaccines, guidelines for regulatory expectations for clinical evaluation of vaccines, guidelines for the production and quality control of inactivated oral cholera vaccines and guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products.
authors.forename: B
authors.initials: B
authors.lastname: Horowitz
authors.forename: P
authors.initials: P
authors.lastname: Minor
authors.forename: J J
authors.initials: JJ
authors.lastname: Morgenthaler
authors.forename: T
authors.initials: T
authors.lastname: Burnouf
authors.forename: R
authors.initials: R
authors.lastname: McIntosh
authors.forename: A
authors.initials: A
authors.lastname: Padilla
authors.forename: R
authors.initials: R
authors.lastname: Thorpe
authors.forename: W G
authors.initials: WG
authors.lastname: van Aken
mesh_terms: D026683:Advisory Committees; D000906:Antibodies; D000941:Antigens; D001688:Biological Products / Q000592:standards*; D001769:Blood; D017408:Guidelines as Topic; D006801:Humans; D022401:Meningococcal Vaccines / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D014612:Vaccines / Q000592:standards; D018074:Vaccines, Conjugate / Q000592:standards; D014944:World Health Organization
chemical_list: D000906:Antibodies; D000941:Antigens; D001688:Biological Products; D022401:Meningococcal Vaccines; D014612:Vaccines; D018074:Vaccines, Conjugate