Records the work of an expert committee commissioned to coordinate a range of research and other activities needed to ensure that biological products conform to international standards of purity, potency, safety, and stability. The book has two parts. The first opens with a brief discussion of selected issues relevant to the production and quality testing of biologicals, followed by comments on the status and development of international biological standards and reference reagents for various antibiotics, antibodies, antigens, blood products, cytokines and growth factors, and endocrinological substances. These international reference materials are held and distributed by four main international laboratories for use in the standardization and control of biologicals. Brief comments alert readers to newly adopted international standards, newly identified needs for international reference materials, and studies being conducted to identify candidate preparations and assess their suitability to serve as international standards. The main part of the report issues detailed requirements for the manufacturing and control of selected biologicals. New requirements are provided for Vi polysaccharide typhoid vaccine, and for live combined measles, mumps and rubella vaccines. Revised requirements for the collection, processing and quality control of blood, blood components and plasma derivatives are also presented, with particular attention given to the extreme care needed during manufacture to ensure that these products are free from infectious viruses, including HIV and hepatitis B virus. The book concludes with amendments to the requirements for three rabies vaccines: rabies vaccine for human use, inactivated rabies vaccine for human use produced in continuous cell lines, and rabies vaccine for veterinary use.

eng fre rus spa.

WHODOC

WHO monograph

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