World Health Organ Tech Rep Ser. 1999;889:i-vi, 1-111.
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, antibiotics, antigens, blood products and related substances, cytokines and growth factors and other substances for which the Committee has discerned a need for international reference materials. The second part of the report, of particular relevance of manufacturers and national control authorities, contains guidelines for the production and control of synthetic peptide vaccines, requirements for tick-borne encephalitis vaccine (inactivated), guidelines for thromboplastins and plasma used to control oral anticoagulant therapy, an amendment to the requirements for hepatitis B vaccine made by recombinant DNA techniques and a report on the standardization and calibration of cytokine immunoassays.
本报告介绍了世界卫生组织一个专家委员会的建议。该委员会受委托协调各项活动，以推动通过疫苗及其他生物制品生产和控制的国际要求，并建立国际生物参考物质。报告开篇讨论了引起委员会关注的一般性问题，并提供了各类抗体、抗生素、抗原、血液制品及相关物质、细胞因子和生长因子以及委员会认为需要国际参考物质的其他物质的参考物质的现状和发展信息。报告的第二部分对制造商和国家监管当局尤为重要，其中包含合成肽疫苗生产和控制指南、蜱传脑炎疫苗（灭活）要求、用于控制口服抗凝治疗的凝血活酶和血浆指南、重组DNA技术生产的乙型肝炎疫苗要求修正案以及细胞因子免疫测定标准化和校准报告。
