Records the deliberations and recommendations of an expert committee commissioned by WHO 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. Addressed to manufacturers, researchers and national control authorities, the report also provides updated information about the availability of international biological standards and reference reagents, which are established by WHO and held and distributed by the four international laboratories for biological standards. The report has three main parts. The first consists of brief comments on a number of topics relevant to the development of international reference materials and the use of different assays in quality control. Topics covered include the need to develop international reference materials for growth factors and cytokines, the urgent need to standardize and improve the reliability of assays for residual DNA, and recommended methods for determining the potency of diphtheria toxoid, antivenoms, oral poliomyelitis vaccine, and live measles vaccine. The second part announces changes in the status of international reference materials for various antibiotics, antibodies, antigens, blood products, endocrinological substances and cytokines. The third and most extensive part includes detailed requirements for the manufacturing and licensing of Haemophilus type b conjugate vaccines and inactivated influenza vaccine. Requirements are intended to help manufacturers and control authorities ensure that these products are safe, reliable, and potent prophylactic or therapeutic agents. The book also establishes guidelines for the quality assurance of pharmaceutical and biological products made using recombinant DNA techniques.

eng fre spa rus.

WHODOC

WHO monograph

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